A Study on the Safety and Immune Responses to the GVGH al... | NCT05073003 | Trialant
NCT05073003
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jun 22, 2026Actual
Enrollment
551Actual
Phase
Phase 1Phase 2
Conditions
Diarrhoea
Interventions
AltSonflex1-2-3 High Dose
AltSonflex1-2-3 Medium Dose
AltSonflex1-2-3 Low Dose
Menveo
Boostrix
INFANRIX HEXA
Typhim-Vi
MR-Vac
altSonflex Placebo
Countries
Belgium
Kenya
Protocol Section
Identification Module
NCT ID
NCT05073003
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
212149
Secondary IDs
ID
Type
Description
Link
2021-000891-12
EudraCT Number
Brief Title
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
Official Title
A Staged Phase I/II Observer-blind, Randomised, Controlled, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against S. Sonnei and S. Flexneri, Serotypes 1b, 2a, and 3a, in Adults in Europe (Stage 1) Followed by Age De-escalation From Adults to Children and Infants, and Dose-finding in Infants in Africa (Stage 2)
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jun 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 6, 2021Actual
Primary Completion Date
Jun 24, 2025Actual
Completion Date
Jun 24, 2025Actual
First Submitted Date
Sep 29, 2021
First Submission Date that Met QC Criteria
Sep 29, 2021
First Posted Date
Oct 11, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Dec 22, 2025
Results First Submitted that Met QC Criteria
Jun 18, 2026
Results First Posted Date
Jun 22, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 18, 2026
Last Update Posted Date
Jun 22, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a. The vaccine was first administered to adults 18 to 50 years of age in Europe. Subsequently, the vaccine was administered to a shigellosis-endemic population in Africa, first to adults 18 to 50 years of age, then to children 24 to 59 months of age, and finally to infants 9 months of age. Infants also received a third vaccination. Three different doses of the vaccine [low, medium, and high amounts of antigen] were evaluated using an age de-escalation approach (from the least vulnerable adult population to the most vulnerable paediatric population). The results of this study allowed the selection of the most appropriate dose for further vaccine development in infants 9 months of age, which was the main target age group for this vaccine.
Detailed Description
Not provided
Conditions Module
Conditions
Diarrhoea
Keywords
Shigella infection
Shigellosis
Diarrhoea
S. sonnei
S. flexneri
Low and middle income countries
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
551Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
Experimental
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) of O-antigen (OAg) each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Biological: AltSonflex1-2-3 High Dose
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
Experimental
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Biological: AltSonflex1-2-3 High Dose
Stage 1 Adults: Placebo Group
Placebo Comparator
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
Drug: altSonflex Placebo
Stage 2 Adults: altSonflex1-2-3 High Dose
Experimental
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AltSonflex1-2-3 High Dose
Biological
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Stage 2: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Shigella Lipopolysaccharide (LPS)/O-Antigen (OAg) Serum Immunoglobulin G (IgG) in Participants 9 Months of Age in Africa
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs were measured by enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL) of serum. Four serotypes were tested. Due to the fact, that the Per protocol set (PPS) for Stage 2 Infants - dose finding cohort had less than the 72 participants per group defined in the protocol as a minimum number of participants to ensure power of the analysis, the Stage 2 Infants Safety cohort and Dose-finding cohort were pooled for the statistical analysis as per the Statistical Analysis Plan. As per protocol, statistical analysis was performed only for the S. sonnei serotype, comparing Stage 2 Infants: Pooled groups (medium vs low dose); and Stage 2 Infants Dose-finding groups (high vs low dose). The objective of this outcome measure is to identify the preferred dose of each component of the altSonflex1-2-3 vaccine for infants 9 months of age in Africa, therefore control groups were not analyzed.
At Day 281 (28 days after the third study intervention)
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Solicited Administration Site Events
The solicited administration site events assessed were erythema, pain, and swelling.
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
Stage 1: Number of Adults 18 to 50 Years of Age in Europe With Solicited Systemic Events
The solicited systemic event assessed was fever. Fever is defined as temperature equal to or above (=>) 38.0°C.
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Unsolicited Adverse Events (AEs)
An unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Secondary Outcomes
Measure
Description
Time Frame
Stage 1: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 18 to 50 Years of Age in Europe
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs were measured by ELISA and expressed in EU/mL of serum. S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes were tested.
At Day 1 and Day 85/Day 169(before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
All participants:
• Participants and/or participants' parent(s)/legally acceptable representative(s) (LARs), who, in the opinion of the investigator, could and would comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
Written or witnessed/thumb-printed informed consent was obtained from the participant/parent(s)/LAR(s) of the participant prior to the performance of any study-specific procedure.
Healthy participants, as established by medical history, clinical examination, and laboratory assessment.
Participants who satisfied all screening requirements.
Participants who were seronegative for hepatitis B and hepatitis C.
Participants who were negative for human leukocyte antigen B27 (HLA-B27).
Adults 18 to 50 years of age:
A male or female between, and including, 18 and 50 years of age at the time of the first study intervention administration.
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
Female participants of childbearing potential may be enrolled in the study, if the participant:
- has practiced adequate contraception for 1 month prior to study intervention administration, and
- has a negative pregnancy test on the day of study intervention administration, and
has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
Participants seronegative for human immunodeficiency virus (HIV).
Children 24 to 59 months of age:
A male or female between, and including, 24 and 59 months of age at the time of first vaccination.
A normal nutritional Z score (-2 standard deviations or greater).
Participants who had previously completed routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR(s).
Participants who were born after a gestation period of ≥37 weeks.
Participants who were seronegative for HIV.
Infants 9 months of age:
A male or female 9 months of age at the time of first vaccination.
A normal nutritional Z score (-2 standard deviations or greater).
Participants who had previously completed routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR(s).
Participants who were born after a gestation period of >=37 weeks.
Participants who were negative for HIV, as confirmed by deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) testing.
Exclusion Criteria:
All participants:
• Known exposure to Shigella during the lifetime of the participant, as confirmed during interview with the participant or documented by patient records (e.g., history of microbiologically confirmed Shigella infection), recent travel* (within 2 years) to a country where Shigella or other enteric infections are endemic, or recent occupation* (within 3 years) involving Shigella species.
Exclusion due to travel or occupation was applicable only to adults 18 to 50 years of age in Europe (Stage 1).
Progressive, unstable, or uncontrolled clinical conditions.
A history (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing was required).
Hypersensitivity, including allergy, to medicinal products or medical equipment whose use was foreseen in this study.
Clinical conditions representing a contraindication to IM vaccination and blood draws.
Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, might have interfered with the participant's ability to participate in the study.
Acute disease and/or fever (defined as temperature ≥38.0°C) at the time of enrolment*.
The participant could still be enrolled into the study at a time when the acute disease and/or fever had resolved.
Any clinically significant haematological and/or biochemical laboratory abnormality.
A confirmed positive COVID-19 test during the period starting 30 days before the first administration of study vaccines (Day -30 to Day 1).
Any other clinical condition that, in the opinion of the investigator, might have posed additional risk to the participant due to participation in the study.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
Prior receipt of an experimental Shigella vaccine or live Shigella challenge.
Use of any investigational or non-registered product (drug, vaccine, or medical device)* other than the study vaccine during the period starting 30 days before the first dose of study intervention (Day -30 to Day 1), or planned use during the study period.
Use of herbs and traditional treatments was not considered an exclusion criterion.
• Administration of a vaccine not foreseen* by the Study Protocol during the period starting at -21 days before the first dose (-28 days in the case of live vaccines) and ending after the last dose of study intervention administration**.
Vaccines allowed by the Protocol included flu and COVID-19 vaccines in all participants and EPI vaccines in children and infants.
*In case of emergency mass vaccination, the time period above could be reduced.
Concurrent participation in another clinical study, at any time during the study period, in which the participant had been or would be exposed to an investigational or non-investigational intervention (drug or invasive medical device).
Any study personnel or immediate dependents, family, or household members.
Adults 18 to 50 years of age:
Acute or chronic illness, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine study intervention. For corticosteroids, this meant a prednisone equivalent ≥20 mg/day for adult participants. Inhaled and topical steroids were allowed.
Pregnant or lactating females.
Females planning to become pregnant or planning to discontinue contraceptive precautions.
A history of or current chronic alcohol consumption and/or drug abuse.
Adults 18 to 50 years of age and children 24 to 59 months of age:
• Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
Children 24 to 59 months of age and infants 9 months of age:
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose. For corticosteroids, this meant prednisone ≥0.5 mg/kg/day or 20 mg/day, whichever was the maximum dose for paediatric participants. Inhaled and topical steroids were allowed.
A child in care.
Infants 9 months of age:
• Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, from birth or planned administration during the study period.
Leroux-Roels I, Maes C, Mancini F, Jacobs B, Sarakinou E, Alhatemi A, Joye J, Grappi S, Cilio GL, Serry-Bangura A, Vitali CG, Ferruzzi P, Marchetti E, Necchi F, Rappuoli R, De Ryck I, Auerbach J, Colucci AM, Rossi O, Conti V, Scorza FB, Arora AK, Micoli F, Podda A, Nakakana UN; Shigella Project Team. Safety and Immunogenicity of a 4-Component Generalized Modules for Membrane Antigens Shigella Vaccine in Healthy European Adults: Randomized, Phase 1/2 Study. J Infect Dis. 2024 Oct 16;230(4):e971-e984. doi: 10.1093/infdis/jiae273.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
As pre-specified in the Statistical Analysis Plan (SAP), the participants that received placebo in Stage 1 were pooled for all analyses (demography, immunogenicity and safety).
Recruitment Details
Out of 551 participants enrolled, 550 started the study and were included in the Exposed set.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
Biological: Menveo
Combination Product: Boostrix
Stage 2 Children: altSonflex1-2-3 Medium Dose
Experimental
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Biological: AltSonflex1-2-3 Medium Dose
Stage 2 Children: altSonflex1-2-3 High Dose
Experimental
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Biological: AltSonflex1-2-3 High Dose
Stage 2 Children: Control
Active Comparator
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Biological: AltSonflex1-2-3 Low Dose
Biological: MR-Vac
Stage 2 Infants safety cohort: altSonflex1-2-3 Medium Dose
Experimental
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Biological: AltSonflex1-2-3 Medium Dose
Biological: MR-Vac
Stage 2 Infants safety cohort: altSonflex1-2-3 High Dose
Experimental
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Biological: AltSonflex1-2-3 High Dose
Biological: MR-Vac
Stage 2 Infants safety cohort: Control
Active Comparator
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Biological: AltSonflex1-2-3 Low Dose
Biological: MR-Vac
Stage 2 Infants dose-finding cohort: altSonflex1-2-3 Medium Dose
Experimental
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Biological: AltSonflex1-2-3 Medium Dose
Biological: MR-Vac
Stage 2 Infants dose-finding cohort: altSonflex1-2-3 High Dose
Experimental
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Biological: AltSonflex1-2-3 High Dose
Biological: MR-Vac
Stage 2 Infants dose-finding cohort: Control
Active Comparator
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Biological: Menveo
Combination Product: INFANRIX HEXA
Biological: MR-Vac
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
Stage 2 Adults: altSonflex1-2-3 High Dose
Stage 2 Children: altSonflex1-2-3 High Dose
Stage 2 Infants dose-finding cohort: altSonflex1-2-3 High Dose
Stage 2 Infants safety cohort: altSonflex1-2-3 High Dose
AltSonflex1-2-3 Medium Dose
Biological
2 doses in children 24-59 months of age, 3 doses in infants 9 months of age
Stage 2 Children: altSonflex1-2-3 Medium Dose
Stage 2 Infants dose-finding cohort: altSonflex1-2-3 Medium Dose
Stage 2 Infants safety cohort: altSonflex1-2-3 Medium Dose
Stage 2 Infants safety cohort: altSonflex1-2-3 Medium Dose
altSonflex Placebo
Drug
2 doses in adults 18-50 years of age (stage 1)
Stage 1 Adults: Placebo Group
Within 28 days after each study intervention (administered at at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
From Day 1 to Day 113 and/or Day 197
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC). Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 8
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 85/Day 169 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 92 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 1), at Day 176 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 2) and at Day 92/Day 176 (Stage 1 Adults: Placebo Group)
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Solicited Administration Site Events
The solicited administration site events assessed were pain, erythema, and swelling.
Within 7 days after each study intervention (administered at Day 1 and Day 85)
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Solicited Systemic Events
The solicited systemic event assessed was fever. Fever is defined as temperature equal to or above (=>) 38.0°C.
Within 7 days after each study intervention (administered at Day 1 and Day 85)
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Unsolicited Adverse Events (AEs)
An unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Within 28 days after each study intervention (administered at Day 1 and Day 85)
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
From Day 1 to Day 113
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 8
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 85 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 92
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Solicited Administration Site Events
The solicited administration site events assessed were erythema, pain, and swelling.
Within 7 days after each study intervention (administered at Day 1 and Day 85)
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Solicited Systemic Events
The solicited systemic event assessed was fever. Fever is defined as temperature equal to or above (=>) 38.0°C.
Within 7 days after each study intervention (administered at Day 1 and Day 85)
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Unsolicited Adverse Events (AEs)
An unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Within 28 days after each study intervention (administered at Day 1 and Day 85)
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
From Day 1 to Day 113
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 8
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 85 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 92
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Administration Site Events - Infants Safety Cohort
The solicited administration site events assessed were erythema, pain, and swelling.
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Administration Site Events - Infants Dose-finding Cohort
The solicited administration site events assessed were erythema, pain, and swelling.
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Systemic Events - Infants Safety Cohort
The solicited systemic event is fever. Fever is defined as temperature equal to or above (=>) 38.0°C.
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Systemic Events - Infants Dose-finding Cohort
The solicited systemic event is fever. Fever is defined as temperature equal to or above (=>) 38.0°C.
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
Stage 2: Number of Participants 9 Months of Age in Africa With Unsolicited Adverse Events (AEs) - Infants Safety Cohort
An unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
Stage 2: Number of Participants 9 Months of Age in Africa With Unsolicited Adverse Events (AEs) - Infants Dose-finding Cohort
An unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
Stage 2: Number of Participants 9 Months of Age in Africa With Serious Adverse Events (SAEs) - Infants Safety Cohort
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
From Day 1 to Day 281
Stage 2: Number of Participants 9 Months of Age in Africa With Serious Adverse Events (SAEs) - Infants Dose-finding Cohort
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
From Day 1 to Day 281
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention - Infants Safety Cohort
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC). Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 8
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention - Infants Dose-finding Cohort
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 8
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention - Infants Safety Cohort
Panel tests include measures of ALT, AST, creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 92
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention - Infants Dose-finding Cohort
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC). Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 92
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Third Study Intervention - Infants Safety Cohort
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 260
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Third Study Intervention - Infants Dose-finding Cohort
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC). Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 260
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 18 to 50 Years of Age in Africa
At Day 1 and Day 85 (before each study intervention administration) and Day 29 and Day 113 (28 days after each study intervention administration)
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 24 to 59 Months of Age in Africa
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 9 Months of Age in Africa - Infants Safety Cohort
At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 9 Months of Age in Africa - Dose-finding Cohort
At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
Stage 1: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
Stage 2: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
Stage 2: Number of Participants 24 to 59 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/Oag - Safety Cohort
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/Oag - Dose-finding Cohort
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
Stage 1: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
Stage 2: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
Stage 2: Number of Participants 24 to 59 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg - Safety Cohort
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg - Dose-finding Cohort
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
Stage 1: Number of Participants 18 to 50 Years of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
At Day 15 (14 days after the first study intervention) and at Day 29 and Day 113/Day 197 (28 days after each study intervention) compared to baseline (Day 1 and Day 85/Day 169)
Stage 2: Number of Participants 18 to 50 Years of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
Stage 2: Number of Participants 24 to 59 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
Stage 2: Number of Participants 9 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA - Safety Cohort
At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
Stage 2: Number of Participants 9 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA - Dose-finding Cohort
At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
Stage 2: Anti-measles IgG Concentrations in Participants 9 Months of Age in the Dose-finding Cohort
At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
Stage 2: Anti-rubella IgG Concentrations in Participants 9 Months of Age in the Dose-finding Groups
At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
Stage 2: Number of Participants 9 Months of Age in the Dose-finding Groups Achieving Anti-measles IgG Concentrations of ≥150 Milli International Units Per Milliliter (mIU/mL) and ≥200 mIU/mL
Day 281 (28 days after the second MR-VAC administration)
Stage 2: Number of Participants 9 Months of Age in the Dose-finding Groups Achieving Anti-rubella IgG Concentrations of ≥4 mIU/mL and ≥10 mIU/mL
Day 281 (28 days after the second MR-VAC administration)
Kericho
20200
Kenya
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
FG002
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
FG003
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
FG004
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
FG005
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
FG006
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
FG007
Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
FG009
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
FG010
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
FG011
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
FG013
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
FG014
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
FG015
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
FG00034 subjects
FG00134 subjects
FG00234 subjects
FG00310 subjects
FG00410 subjects
FG00510 subjects
FG00610 subjects
FG00720 subjects
FG00810 subjects
FG00910 subjects
FG01010 subjects
FG01130 subjects
FG01282 subjects
FG01381 subjects
FG01483 subjects
FG01582 subjects
COMPLETED
FG00029 subjects
FG00134 subjects
FG00228 subjects
FG00310 subjects
FG00410 subjects
FG00510 subjects
FG00610 subjects
FG00720 subjects
FG0089 subjects
FG0098 subjects
FG01010 subjects
FG01127 subjects
FG01269 subjects
FG01371 subjects
FG01473 subjects
FG01571 subjects
NOT COMPLETED
FG0005 subjects
FG0010 subjects
FG0026 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0092 subjects
FG0100 subjects
FG0113 subjects
FG01213 subjects
FG01310 subjects
FG01410 subjects
FG01511 subjects
Type
Comment
Reasons
Adverse Events (including death)
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
FG0150 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Consent withdrawal, not due to a (Serious) Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Migrated / moved from the study area
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0002 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
BG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
BG002
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
BG003
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
BG004
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
BG005
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
BG006
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
BG007
Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
BG009
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
BG010
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
BG011
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
BG013
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
BG014
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
BG015
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
BG016
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00034
BG00134
BG00234
BG00310
BG00410
BG00510
BG00610
BG00720
BG00810
BG00910
BG01010
BG01130
BG01282
BG01381
BG01483
BG01582
BG016550
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00028
BG00127
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
BLACK OR AFRICAN AMERICAN
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Stage 2: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Shigella Lipopolysaccharide (LPS)/O-Antigen (OAg) Serum Immunoglobulin G (IgG) in Participants 9 Months of Age in Africa
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs were measured by enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL) of serum. Four serotypes were tested. Due to the fact, that the Per protocol set (PPS) for Stage 2 Infants - dose finding cohort had less than the 72 participants per group defined in the protocol as a minimum number of participants to ensure power of the analysis, the Stage 2 Infants Safety cohort and Dose-finding cohort were pooled for the statistical analysis as per the Statistical Analysis Plan. As per protocol, statistical analysis was performed only for the S. sonnei serotype, comparing Stage 2 Infants: Pooled groups (medium vs low dose); and Stage 2 Infants Dose-finding groups (high vs low dose). The objective of this outcome measure is to identify the preferred dose of each component of the altSonflex1-2-3 vaccine for infants 9 months of age in Africa, therefore control groups were not analyzed.
The analysis was performed on the PPS for Stage 2 Infants which included all eligible participants who received all doses as per protocol,had immunogenicity results post-dose,complied with dosing/blood draw intervals,without intercurrent conditions that may interfere with immunogenicity & without prohibited concomitant medication/vaccination.The PPS for immunogenicity was defined by time point.
Posted
Geometric Mean
95% Confidence Interval
ELISA units per milliliter (EU/mL)
At Day 281 (28 days after the third study intervention)
ID
Title
Description
OG000
Stage 2 Infants: altSonflex1-2-3 Low Dose Pooled
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered either on Day 1 and Day 253 or on Day 29 and Day 281. This group was obtained by pooling the Stage 2 Infants safety cohort: altSonflex1-2-3 Low Dose group and the Stage 2 Infants dose-finding cohort: altSonflex1-2-3 Low Dose group.
OG001
Stage 2 Infants: altSonflex1-2-3 Medium Dose Pooled
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered either on Day 1 and Day 253 or on Day 29 and Day 281. This group was obtained by pooling the Stage 2 Infants safety cohort: altSonflex1-2-3 Medium Dose group and the Stage 2 Infants dose-finding cohort: altSonflex1-2-3 Medium Dose group.
OG002
Stage 2 Infants: altSonflex1-2-3 High Dose Pooled
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered either on Day 1 and Day 253 or on Day 29 and Day 281. This group was obtained by pooling the Stage 2 Infants safety cohort: altSonflex1-2-3 High Dose group and the Stage 2 Infants dose-finding cohort: altSonflex1-2-3 High Dose group.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG004
Units
Counts
Participants
OG00075
OG00172
OG00280
OG003
Title
Denominators
Categories
S. sonnei Ab IgG
Title
Measurements
OG000379.3(81.4 to 1766.5)
OG001463.5(95.0 to 2261.3)
OG002457.6(94.7 to 2211.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To identify the preferred dose of S. sonnei component of the vaccine (medium vs. low) for infants 9 months of age in Africa. The statistical tests to identify the preferred dose among the 3 different dose levels (Dose A, Dose B, and Dose C) in infants were defined according to GMCs dose-response shapes of each of the 4 components as measured by GVGH ELISA. The selection strategy had been predefined for each of the possible scenarios of the dose-response shapes.
t-test, 2 sided
Restricted maximum likelihood was used to estimate the variance components, Kenward-Roger approximation was used to calculate the degrees of freedom.
0.273
Geometric Mean Concentration Ratio
1.22
2-Sided
95
0.85
1.75
Primary
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Solicited Administration Site Events
The solicited administration site events assessed were erythema, pain, and swelling.
The analysis was performed on the Solicited Safety Set for Stage 1 Adults which included all participants who received at least 1 dose of the study intervention, who have solicited safety data. As the participants in Stage 1 Adults: Placebo Group received the second placebo intervention at Day 85 or at Day 169, the analysis being performed on the pooled participants as per the SAP, no differentiation was made by timepoint of administration for the second dose for this group.
Posted
Count of Participants
Participants
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
ID
Title
Description
OG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 1: Number of Adults 18 to 50 Years of Age in Europe With Solicited Systemic Events
The solicited systemic event assessed was fever. Fever is defined as temperature equal to or above (=>) 38.0°C.
The analysis was performed on the Solicited Safety Set for Stage 1 Adults. As the participants in Stage 1 Adults: Placebo Group received the second placebo intervention at Day 85 or at Day 169, the analysis being performed on the pooled participants as per the SAP, no differentiation was made by timepoint of administration for the second dose for this group.
Posted
Count of Participants
Participants
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
ID
Title
Description
OG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Unsolicited Adverse Events (AEs)
An unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
The analysis was performed on the Unsolicited Safety Set for Stage 1 Adults which included all participants who received at least 1 dose of the study intervention that reported having/not having unsolicited AEs. As the participants in Stage 1 Adults: Placebo Group received the second placebo intervention at Day 85 or at Day 169, the analysis being performed on the pooled participants as per the SAP, no differentiation was made by timepoint of administration for the second dose for this group.
Posted
Count of Participants
Participants
Within 28 days after each study intervention (administered at at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
ID
Title
Description
OG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
The analysis was performed on the Exposed Set for Stage 1 Adults which included all participants who received at least 1 dose of the study intervention. As the participants in Stage 1 Adults: Placebo Group received the second placebo intervention at Day 85 or at Day 169, the analysis being performed on the pooled participants as per the SAP, no differentiation was made by timepoint of administration for the second dose for this group.
Posted
Count of Participants
Participants
From Day 1 to Day 113 and/or Day 197
ID
Title
Description
OG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC). Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 1 Adults.
Posted
Count of Participants
Participants
At Day 8
ID
Title
Description
OG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 85/Day 169 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 1 Adults.
Posted
Count of Participants
Participants
At Day 92 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 1), at Day 176 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 2) and at Day 92/Day 176 (Stage 1 Adults: Placebo Group)
ID
Title
Description
OG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
Primary
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Solicited Administration Site Events
The solicited administration site events assessed were pain, erythema, and swelling.
The analysis was performed on the Solicited Safety Set for Stage 2 Adults.
Posted
Count of Participants
Participants
Within 7 days after each study intervention (administered at Day 1 and Day 85)
ID
Title
Description
OG000
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
Units
Counts
Participants
Primary
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Solicited Systemic Events
The solicited systemic event assessed was fever. Fever is defined as temperature equal to or above (=>) 38.0°C.
The analysis was performed on the Solicited Safety Set for Stage 2 Adults.
Posted
Count of Participants
Participants
Within 7 days after each study intervention (administered at Day 1 and Day 85)
ID
Title
Description
OG000
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
Units
Counts
Participants
Primary
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Unsolicited Adverse Events (AEs)
An unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
The analysis was performed on the Unsolicited Safety Set for Stage 2 Adults.
Posted
Count of Participants
Participants
Within 28 days after each study intervention (administered at Day 1 and Day 85)
ID
Title
Description
OG000
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
Units
Counts
Participants
Primary
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
The analysis was performed on the Exposed Set for Stage 2 Adults.
Posted
Count of Participants
Participants
From Day 1 to Day 113
ID
Title
Description
OG000
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
Units
Counts
Primary
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 2 Adults.
Posted
Count of Participants
Participants
At Day 8
ID
Title
Description
OG000
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
Primary
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 85 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 2 Adults.
Posted
Count of Participants
Participants
At Day 92
ID
Title
Description
OG000
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
Primary
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Solicited Administration Site Events
The solicited administration site events assessed were erythema, pain, and swelling.
The analysis was performed on the Solicited Safety Set for Stage 2 Children.
Posted
Count of Participants
Participants
Within 7 days after each study intervention (administered at Day 1 and Day 85)
ID
Title
Description
OG000
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
Primary
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Solicited Systemic Events
The solicited systemic event assessed was fever. Fever is defined as temperature equal to or above (=>) 38.0°C.
The analysis was performed on the Solicited Safety Set for Stage 2 Children.
Posted
Count of Participants
Participants
Within 7 days after each study intervention (administered at Day 1 and Day 85)
ID
Title
Description
OG000
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
Primary
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Unsolicited Adverse Events (AEs)
An unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
The analysis was performed on the Unsolicited Safety Set for Stage 2: Children.
Posted
Count of Participants
Participants
Within 28 days after each study intervention (administered at Day 1 and Day 85)
ID
Title
Description
OG000
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Children: Control
Primary
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
The analysis was performed on the Exposed Set for Stage 2 Children.
Posted
Count of Participants
Participants
From Day 1 to Day 113
ID
Title
Description
OG000
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Children: Control
Primary
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 2 Children.
Posted
Count of Participants
Participants
At Day 8
ID
Title
Description
OG000
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 85 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 2 Children.
Posted
Count of Participants
Participants
At Day 92
ID
Title
Description
OG000
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Administration Site Events - Infants Safety Cohort
The solicited administration site events assessed were erythema, pain, and swelling.
The analysis was performed on the solicited Safety Set for Stage 2 Infants, safety cohort.
Posted
Count of Participants
Participants
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Administration Site Events - Infants Dose-finding Cohort
The solicited administration site events assessed were erythema, pain, and swelling.
The analysis was performed on the Solicited Safety Set for Stage 2 Infants, dose-finding cohort.
Posted
Count of Participants
Participants
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Systemic Events - Infants Safety Cohort
The solicited systemic event is fever. Fever is defined as temperature equal to or above (=>) 38.0°C.
The analysis was performed on the Solicited Safety Set for Stage 2 Infants, safety cohort.
Posted
Count of Participants
Participants
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Systemic Events - Infants Dose-finding Cohort
The solicited systemic event is fever. Fever is defined as temperature equal to or above (=>) 38.0°C.
The analysis was performed on the Solicited Safety Set for Stage 2 Infants, dose finding cohort.
Posted
Count of Participants
Participants
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Unsolicited Adverse Events (AEs) - Infants Safety Cohort
An unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
The analysis was performed on the Unsolicited Safety Set for Stage 2 Infants, safety cohort.
Posted
Count of Participants
Participants
Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Unsolicited Adverse Events (AEs) - Infants Dose-finding Cohort
An unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
The analysis was performed on the Unsolicited Safety Set for Stage 2 Infants, dose-finding cohort.
Posted
Count of Participants
Participants
Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Serious Adverse Events (SAEs) - Infants Safety Cohort
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
The analysis was performed on the Exposed Set for Stage 2 Infants, safety cohort.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Serious Adverse Events (SAEs) - Infants Dose-finding Cohort
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
The analysis was performed on the Exposed Set for Stage 2 Infants, dose-finding cohort.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention - Infants Safety Cohort
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC). Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 2 Infants, safety cohort.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention - Infants Dose-finding Cohort
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 2 Infants.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention - Infants Safety Cohort
Panel tests include measures of ALT, AST, creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 2 Infants, safety cohort. Potassium, sodium and urea have been collected only after Protocol Amendment 4 was effective, therefore there is no data to report for Stage 2 Infants Safety Cohort: altSonflex1-2-3 Low Dose and Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose groups.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention - Infants Dose-finding Cohort
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC). Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 2 Infants, dose-finding cohort.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Third Study Intervention - Infants Safety Cohort
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC. Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 2 Infants, safety cohort.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Primary
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Third Study Intervention - Infants Dose-finding Cohort
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC). Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
The analysis was performed on the Exposed Set for Stage 2 Infants, dose-finding cohort.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
Secondary
Stage 1: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 18 to 50 Years of Age in Europe
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs were measured by ELISA and expressed in EU/mL of serum. S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes were tested.
The analysis was performed on the PPS for Stage 1 Adults. As the participants in Stage 1 Adults: Placebo Group received the second placebo intervention at Day 85 or at Day 169, the analysis being performed on the pooled participants as per the SAP, no differentiation was made by timepoint of administration for the second dose for this group.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At Day 1 and Day 85/Day 169(before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
ID
Title
Description
OG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Secondary
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 18 to 50 Years of Age in Africa
The analysis was performed on the PPS for Stage 2 Adults.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At Day 1 and Day 85 (before each study intervention administration) and Day 29 and Day 113 (28 days after each study intervention administration)
ID
Title
Description
OG000
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
Units
Counts
Participants
OG000
Secondary
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 24 to 59 Months of Age in Africa
The analysis was performed on the PPS for Stage 2 Children.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
ID
Title
Description
OG000
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
Secondary
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 9 Months of Age in Africa - Infants Safety Cohort
The analysis was performed on the PPS for Stage 2 Infants, safety cohort.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
Secondary
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 9 Months of Age in Africa - Dose-finding Cohort
The analysis was performed on the PPS for Stage 2 Infants, dose-finding cohort.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Secondary
Stage 1: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
The analysis was performed on the PPS for Stage 1 Adults. As the participants in Stage 1 Adults: Placebo Group received the second placebo intervention at Day 85 or at Day 169, the analysis being performed on the pooled participants as per the SAP, no differentiation was made by timepoint of administration for the second dose for this group.
Posted
Count of Participants
Participants
At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
ID
Title
Description
OG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Secondary
Stage 2: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
The analysis was performed on the PPS for Stage 2 Adults.
Posted
Count of Participants
Participants
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
ID
Title
Description
OG000
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
Units
Counts
Participants
OG000
Secondary
Stage 2: Number of Participants 24 to 59 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
The analysis was performed on the PPS for Stage 2 Children.
Posted
Count of Participants
Participants
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
ID
Title
Description
OG000
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
Secondary
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/Oag - Safety Cohort
The analysis was performed on the PPS for Stage 2 Infants, safety cohort.
Posted
Count of Participants
Participants
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
Secondary
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/Oag - Dose-finding Cohort
The analysis was performed on the PPS for Stage 2 Infants, dose-finding cohort.
Posted
Count of Participants
Participants
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Secondary
Stage 1: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
The analysis was performed on the PPS for Stage 1 Adults. As the participants in Stage 1 Adults: Placebo Group received the second placebo intervention at Day 85 or at Day 169, the analysis being performed on the pooled participants as per the SAP, no differentiation was made by timepoint of administration for the second dose for this group.
Posted
Count of Participants
Participants
At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
ID
Title
Description
OG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Secondary
Stage 2: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
The analysis was performed on the PPS for Stage 2 Adults.
Posted
Count of Participants
Participants
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
ID
Title
Description
OG000
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
Units
Counts
Participants
OG000
Secondary
Stage 2: Number of Participants 24 to 59 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
The analysis was performed on the PPS for Stage 2 Children.
Posted
Count of Participants
Participants
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
ID
Title
Description
OG000
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
Secondary
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg - Safety Cohort
The analysis was performed on the PPS for Stage 2 Infants, safety cohort.
Posted
Count of Participants
Participants
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
Secondary
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg - Dose-finding Cohort
The analysis was performed on the PPS for Stage 2 Infants, dose-finding cohort.
Posted
Count of Participants
Participants
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Secondary
Stage 1: Number of Participants 18 to 50 Years of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
The analysis was performed on the PPS for Stage 1 Adults. As the participants in Stage 1 Adults: Placebo Group received the second placebo intervention at Day 85 or at Day 169, the analysis being performed on the pooled participants as per the SAP, no differentiation was made by timepoint of administration for the second dose for this group.
Posted
Count of Participants
Participants
At Day 15 (14 days after the first study intervention) and at Day 29 and Day 113/Day 197 (28 days after each study intervention) compared to baseline (Day 1 and Day 85/Day 169)
ID
Title
Description
OG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Secondary
Stage 2: Number of Participants 18 to 50 Years of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
The analysis was performed on the PPS for Stage 2 Adults.
Posted
Count of Participants
Participants
At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
ID
Title
Description
OG000
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
Units
Counts
Participants
OG000
Secondary
Stage 2: Number of Participants 24 to 59 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
The analysis was performed on the PPS for Stage 2 Children.
Posted
Count of Participants
Participants
At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
ID
Title
Description
OG000
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
Secondary
Stage 2: Number of Participants 9 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA - Safety Cohort
The analysis was performed on the PPS for Stage 2 Infants, safety cohort.
Posted
Count of Participants
Participants
At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
Secondary
Stage 2: Number of Participants 9 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA - Dose-finding Cohort
The analysis was performed on the PPS for Stage 2 Infants, dose-finding cohort.
Posted
Count of Participants
Participants
At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
Secondary
Stage 2: Anti-measles IgG Concentrations in Participants 9 Months of Age in the Dose-finding Cohort
The analysis was performed on the PPS for Stage 2 Infants, dose-finding cohort.
Posted
Geometric Mean
95% Confidence Interval
mIU/mL
At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
Secondary
Stage 2: Anti-rubella IgG Concentrations in Participants 9 Months of Age in the Dose-finding Groups
The analysis was performed on the PPS for Stage 2 Infants, dose-finding cohort.
Posted
Geometric Mean
95% Confidence Interval
mIU/mL
At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
Secondary
Stage 2: Number of Participants 9 Months of Age in the Dose-finding Groups Achieving Anti-measles IgG Concentrations of ≥150 Milli International Units Per Milliliter (mIU/mL) and ≥200 mIU/mL
The analysis was performed on the PPS for Stage 2 Infants dose-finding cohort.
Posted
Count of Participants
Participants
Day 281 (28 days after the second MR-VAC administration)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
Secondary
Stage 2: Number of Participants 9 Months of Age in the Dose-finding Groups Achieving Anti-rubella IgG Concentrations of ≥4 mIU/mL and ≥10 mIU/mL
The analysis was performed on the PPS for Stage 2 Infants, dose-finding cohort.
Posted
Count of Participants
Participants
Day 281 (28 days after the second MR-VAC administration)
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG001
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
Time Frame
Solicited AEs were collected within 7 days and unsolicited AEs within 28 days after any intervention (administered on Day (D) 1 and D85 for Stage 1 adults, Stage 2 adults and children and D1, D85 and D253 for Stage 2 infants). SAEs and all-cause mortality: from Day (D) 1 to D113/D197 for stage 1, from D1 to D113 for Stage 2 adults & children, from D1 to D281 for Stage 2 infants.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) O-antigen (OAg) of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
0
34
0
34
33
34
EG001
Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
0
34
1
34
33
34
EG002
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
0
34
0
34
32
34
EG003
Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
0
10
0
10
7
10
EG004
Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
0
10
0
10
5
10
EG005
Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
0
10
0
10
9
10
EG006
Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
0
10
0
10
5
10
EG007
Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
0
10
0
10
6
10
EG009
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
0
10
0
10
8
10
EG010
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
0
10
0
10
10
10
EG011
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
0
82
2
82
77
82
EG013
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
1
81
1
81
74
81
EG014
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
0
83
4
83
80
83
EG015
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
0
82
1
82
69
82
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Faecaloma
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected10 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected30 at risk
EG0120 events0 affected82 at risk
EG0130 events0 affected81 at risk
EG0140 events0 affected83 at risk
EG0150 events0 affected82 at risk
Stomatitis
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Gastroenteritis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Oral candidiasis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pneumonia
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Epilepsy
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Infantile spasms
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected10 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected30 at risk
EG0121 events1 affected82 at risk
EG0130 events0 affected81 at risk
EG0140 events0 affected83 at risk
EG0150 events0 affected82 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Palpitations
Cardiac disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Tachycardia
Cardiac disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Autoimmune hypothyroidism
Endocrine disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Conjunctivitis allergic
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Eye irritation
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Eye pruritus
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Lacrimation increased
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Abdominal distension
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Abdominal pain
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Cheilitis
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Constipation
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Diarrhoea
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected34 at risk
EG003
Enteritis
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Faeces hard
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Flatulence
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Gastritis
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Mucous stools
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Nausea
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0002 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Toothache
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Vomiting
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Administration site erythema
General disorders
v28.0
Systematic Assessment
EG0006 events5 affected34 at risk
EG00110 events8 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Administration site pain
General disorders
v28.0
Systematic Assessment
EG00054 events33 affected34 at risk
EG00164 events33 affected34 at risk
EG00224 events20 affected34 at risk
EG003
Administration site swelling
General disorders
v28.0
Systematic Assessment
EG0007 events5 affected34 at risk
EG00112 events9 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Application site hypersensitivity
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Axillary pain
General disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Chills
General disorders
v28.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0012 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Fatigue
General disorders
v28.0
Systematic Assessment
EG0005 events4 affected34 at risk
EG0011 events1 affected34 at risk
EG0022 events2 affected34 at risk
EG003
Feeling hot
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Influenza like illness
General disorders
v28.0
Systematic Assessment
EG0004 events3 affected34 at risk
EG0015 events5 affected34 at risk
EG0024 events4 affected34 at risk
EG003
Injection site discolouration
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Injection site eczema
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Injection site erythema
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Injection site haematoma
General disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Injection site induration
General disorders
v28.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0012 events2 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Injection site nodule
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Injection site pain
General disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0013 events3 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Injection site rash
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Injection site reaction
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected34 at risk
EG003
Injection site warmth
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0014 events3 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Malaise
General disorders
v28.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Peripheral swelling
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pyrexia
General disorders
v28.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Swelling face
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Vaccination site pain
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Food allergy
Immune system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Abscess limb
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Amoebiasis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Amoebic dysentery
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Bacterial infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Body tinea
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Bronchiolitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Bronchitis
Infections and infestations
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
COVID-19
Infections and infestations
v28.0
Systematic Assessment
EG0004 events4 affected34 at risk
EG0011 events1 affected34 at risk
EG0026 events6 affected34 at risk
EG003
Cellulitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Conjunctivitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Cystitis
Infections and infestations
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Dermatitis infected
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Ear infection
Infections and infestations
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Furuncle
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Gastroenteritis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Genital abscess
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Helminthic infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Infectious mononucleosis
Infections and infestations
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Labyrinthitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Lower respiratory tract infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Malaria
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Nasopharyngitis
Infections and infestations
v28.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0011 events1 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Oral candidiasis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Otitis media
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Otitis media acute
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pharyngitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Plasmodium falciparum infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pneumonia
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Rhinitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0012 events2 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Scabies
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Sinusitis
Infections and infestations
v28.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0012 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Tonsillitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Upper respiratory tract infection
Infections and infestations
v28.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected34 at risk
EG003
Varicella
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Face injury
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Greenstick fracture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Immunisation reaction
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Alanine aminotransferase increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Blood potassium increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Blood sodium increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Eosinophil count increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Haemoglobin decreased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Hepatic enzyme increased
Investigations
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Lymphocyte count increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Neutrophil count decreased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Platelet count increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Respiratory rate increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
White blood cell count increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected34 at risk
EG003
Myalgia intercostal
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Dizziness
Nervous system disorders
v28.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Headache
Nervous system disorders
v28.0
Systematic Assessment
EG00016 events12 affected34 at risk
EG00113 events10 affected34 at risk
EG00213 events8 affected34 at risk
EG003
Hypoaesthesia
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Hypotonia
Nervous system disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Migraine
Nervous system disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Partial seizures
Nervous system disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Syncope
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Tension headache
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Allergic cough
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0012 events2 affected34 at risk
EG0023 events3 affected34 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0012 events2 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine
C057664
Vi polysaccharide vaccine, typhoid
Ancestor Terms
ID
Term
D001428
Bacterial Vaccines
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0133 subjects
FG0142 subjects
FG0155 subjects
FG004
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0112 subjects
FG0129 subjects
FG0134 subjects
FG0145 subjects
FG0155 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
FG0122 subjects
FG0132 subjects
FG0142 subjects
FG0150 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0141 subjects
FG0151 subjects
0
BG0040
BG00510
BG00610
BG00720
BG00810
BG00910
BG01010
BG01130
BG01282
BG01381
BG01483
BG01582
BG016428
Between 18 and 65 years
BG00034
BG00134
BG00234
BG00310
BG00410
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG016122
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
27
BG0036
BG0046
BG0054
BG0064
BG00711
BG0087
BG0095
BG0104
BG01116
BG01232
BG01343
BG01441
BG01549
BG016310
Male
BG0006
BG0017
BG0027
BG0034
BG0044
BG0056
BG0066
BG0079
BG0083
BG0095
BG0106
BG01114
BG01250
BG01338
BG01442
BG01533
BG016240
0
BG00310
BG00410
BG00510
BG00610
BG00720
BG00810
BG00910
BG01010
BG01130
BG01282
BG01381
BG01483
BG01582
BG016448
WHITE
Title
Measurements
BG00034
BG00134
BG00234
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG016102
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG005
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
66
OG00464
OG00571
OG003
437.3
(335.3 to 570.4)
OG004577.5(449.7 to 741.7)
OG005584.3(451.9 to 755.5)
S. flexneri 1b Ab IgG
Title
Measurements
OG00051.1(39.3 to 66.4)
OG00132.1(25.6 to 40.4)
OG00235.6(28.3 to 44.8)
OG00356.6(44.0 to 72.9)
OG00433.1(25.1 to 43.7)
OG00535.1(27.0 to 45.7)
S. flexneri 2a Ab IgG
Title
Measurements
OG000177.8(57.4 to 550.6)
OG001135.3(34.0 to 537.9)
OG002173.8(62.4 to 484.0)
OG003186.3(141.2 to 245.8)
OG004145.9(115.2 to 184.9)
OG005180.8(136.9 to 238.7)
S. flexneri 3a Ab IgG
Title
Measurements
OG00032.6(6.1 to 173.2)
OG00124.4(4.8 to 125.4)
OG00227.5(5.0 to 152.2)
OG00339.7(28.9 to 54.6)
OG00430.4(22.3 to 41.5)
OG00536.6(25.8 to 51.9)
Other
Non-inferiority or equivalence analysis has not been performed, this is a pair-wise comparison. Results are based on a linear mixed model with fixed effect for treatment, timepoint, baseline value, treatment*timepoint, random effect for cohort and a repeated timepoint effect within a participant under an unstructured covariance matrix. Model assumes unequal variances between treatment groups.
OG003
OG005
To identify the preferred dose of S. sonnei component of the vaccine (high vs. low) for infants 9 months of age in Africa. The statistical tests to identify the preferred dose among the 3 different dose levels (Dose A, Dose B, and Dose C) in infants were defined according to GMCs dose-response shapes of each of the 4 components as measured by GVGH ELISA. The selection strategy had been predefined for each of the possible scenarios of the dose-response shapes.
t-test, 2 sided
Restricted maximum likelihood was used to estimate the variance components, Kenward-Roger approximation was used to calculate the degrees of freedom.
0.120
Results are based on a linear mixed model with fixed effect for treatment, timepoint, baseline value, treatment*timepoint, random effect for cohort and a repeated timepoint effect within a participant under an unstructured covariance matrix.
Geometric Mean Concentration Ratio
1.34
2-Sided
95
0.93
1.93
Other
Non-inferiority or equivalence analysis has not been performed, this is a pair-wise comparison. Results are based on a linear mixed model with fixed effect for treatment, timepoint, baseline value, treatment*timepoint, random effect for cohort and a repeated timepoint effect within a participant under an unstructured covariance matrix. Model assumes unequal variances between treatment groups.
OG002
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
Units
Counts
Participants
OG00034
OG00134
OG00234
Title
Denominators
Categories
Erythema, Vaccination at Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
Title
Measurements
OG0004
OG0016
OG0021
Erythema, Vaccination at Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Erythema, Vaccination at 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
Erythema, Vaccination at Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
Pain, Vaccination at Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
Title
Measurements
OG000
Pain, Vaccination at Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Pain, Vaccination at Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
Pain, Vaccination at Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
Swelling, Vaccination at Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
Title
Measurements
OG000
Swelling, Vaccination at Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Swelling, Vaccination at 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
Swelling, Vaccination at Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
OG002
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
Units
Counts
Participants
OG00034
OG00134
OG00234
Title
Denominators
Categories
Within 7 days after vaccination at Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
Title
Measurements
OG0000
OG0011
OG0020
Within 7 days after vaccination at Day 85
ParticipantsOG00029
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Within 7 days after vaccination at Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
Within 7 days after vaccination at Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00234
Title
Measurements
OG002
OG002
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
Units
Counts
Participants
OG00034
OG00134
OG00234
Title
Denominators
Categories
Within 28 days after vaccination at Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
Title
Measurements
OG00025
OG00121
OG00225
Within 28 days after vaccination at Day 85
ParticipantsOG00029
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Within 28 days after vaccination at Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
Within 28 days after vaccination at Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00234
Title
Measurements
OG002
OG002
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
Units
Counts
Participants
OG00034
OG00134
OG00234
Title
Denominators
Categories
From Day 1 to Day 113
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0000
From Day 1 to Day 197
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
From Day 1 to Day 113/197
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00234
Title
Measurements
OG002
OG002
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
Units
Counts
Participants
OG00034
OG00134
OG00234
Title
Denominators
Categories
ALT, Within, Within
Title
Measurements
OG00032
OG00133
OG00230
ALT, Within, Above
Title
Measurements
OG0001
OG0010
OG0021
ALT, Above, Within
Title
Measurements
OG0001
OG0010
OG0021
ALT, Above, Above
Title
Measurements
OG0000
OG0011
OG0022
AST, Within, Within
Title
Measurements
OG00031
OG00133
OG00231
AST, Within, Above
Title
Measurements
OG0000
OG0010
OG0023
AST, Above, Within
Title
Measurements
OG0003
OG0010
OG0020
AST, Above, Above
Title
Measurements
OG0000
OG0011
OG0020
Creatinine, Within, Within
Title
Measurements
OG00033
OG00134
OG00234
Creatinine, Above, Above
Title
Measurements
OG0001
OG0010
OG0020
Basophils, Below, Below
Title
Measurements
OG0000
OG0010
OG0021
Basophils, Below, Within
Title
Measurements
OG0003
OG0010
OG0021
Basophils, Within, Below
Title
Measurements
OG0000
OG0010
OG0021
Basophils, Within, Within
Title
Measurements
OG00031
OG00133
OG00231
Basophils, Above, Within
Title
Measurements
OG0000
OG0011
OG0020
Eosinophils, Below, Within
Title
Measurements
OG0001
OG0011
OG0021
Eosinophils, Within, Below
Title
Measurements
OG0000
OG0012
OG0020
Eosinophils, Within, Within
Title
Measurements
OG00032
OG00130
OG00231
Eosinophils, Within, Above
Title
Measurements
OG0000
OG0010
OG0021
Eosinophils, Above, Within
Title
Measurements
OG0001
OG0010
OG0020
Eosinophils, Above, Above
Title
Measurements
OG0000
OG0011
OG0021
Erythrocytes, Below, Below
Title
Measurements
OG0001
OG0010
OG0020
Erythrocytes, Below, Within
Title
Measurements
OG0001
OG0010
OG0020
Erythrocytes, Within, Below
Title
Measurements
OG0000
OG0011
OG0020
Erythrocytes, Within, Within
Title
Measurements
OG00032
OG00132
OG00233
Erythrocytes, Above, Within
Title
Measurements
OG0000
OG0011
OG0021
Haematocrit, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
Haematocrit, Below, Within
Title
Measurements
OG0001
OG0010
OG0021
Haematocrit, Within, Within
Title
Measurements
OG00032
OG00132
OG00233
Haematocrit, Above, Within
Title
Measurements
OG0001
OG0010
OG0020
Haematocrit, Above, Above
Title
Measurements
OG0000
OG0011
OG0020
Haemoglobin, Below, Below
Title
Measurements
OG0001
OG0011
OG0020
Haemoglobin, Below, Within
Title
Measurements
OG0002
OG0011
OG0020
Haemoglobin, Within, Below
Title
Measurements
OG0000
OG0011
OG0020
Haemoglobin, Within, Within
Title
Measurements
OG00030
OG00128
OG00233
Haemoglobin, Within, Above
Title
Measurements
OG0000
OG0011
OG0020
Haemoglobin, Above, Within
Title
Measurements
OG0001
OG0011
OG0021
Haemoglobin, Above, Above
Title
Measurements
OG0000
OG0011
OG0020
Lymphocytes, Below, Below
Title
Measurements
OG0002
OG0012
OG0020
Lymphocytes, Below, Within
Title
Measurements
OG0001
OG0010
OG0021
Lymphocytes, Within, Within
Title
Measurements
OG00031
OG00132
OG00231
Lymphocytes, Within, Above
Title
Measurements
OG0000
OG0010
OG0022
Monocytes, Below, Within
Title
Measurements
OG0000
OG0011
OG0021
Monocytes, Within, Below
Title
Measurements
OG0001
OG0010
OG0020
Monocytes, Within, Within
Title
Measurements
OG00033
OG00133
OG00231
Monocytes, Above, Within
Title
Measurements
OG0000
OG0010
OG0021
Monocytes, Above, Above
Title
Measurements
OG0000
OG0010
OG0021
Neutrophils, Below, Within
Title
Measurements
OG0001
OG0010
OG0021
Neutrophils, Below, Above
Title
Measurements
OG0001
OG0010
OG0020
Neutrophils, Within, Below
Title
Measurements
OG0000
OG0012
OG0021
Neutrophils, Within, Within
Title
Measurements
OG00028
OG00128
OG00232
Neutrophils, Within, Above
Title
Measurements
OG0001
OG0013
OG0020
Neutrophils, Above, Within
Title
Measurements
OG0003
OG0011
OG0020
Platelets, Below, Within
Title
Measurements
OG0000
OG0011
OG0022
Platelets, Within, Within
Title
Measurements
OG00029
OG00128
OG00229
Platelets, Within, Above
Title
Measurements
OG0000
OG0013
OG0021
Platelets, Above, Within
Title
Measurements
OG0001
OG0010
OG0021
Platelets, Above, Above
Title
Measurements
OG0004
OG0012
OG0021
WBC, Below, Within
Title
Measurements
OG0002
OG0011
OG0022
WBC, Within, Below
Title
Measurements
OG0001
OG0014
OG0020
WBC, Within, Within
Title
Measurements
OG00030
OG00129
OG00232
WBC, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
Units
Counts
Participants
OG00029
OG00134
OG00228
Title
Denominators
Categories
ALT, Within, Within
Title
Measurements
OG00026
OG00132
OG00226
ALT, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
ALT, Above, Within
Title
Measurements
OG0001
OG0011
OG0021
ALT, Above, Above
Title
Measurements
OG0001
OG0011
OG0021
AST, Within, Within
Title
Measurements
OG00027
OG00132
OG00227
AST, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
AST, Above, Within
Title
Measurements
OG0001
OG0011
OG0021
AST, Above, Above
Title
Measurements
OG0000
OG0011
OG0020
Creatinine, Within, Within
Title
Measurements
OG00028
OG00134
OG00227
Creatinine, Within, Above
Title
Measurements
OG0000
OG0010
OG0021
Creatinine, Above, Above
Title
Measurements
OG0001
OG0010
OG0020
Basophils, Below, Below
Title
Measurements
OG0000
OG0010
OG0021
Basophils, Below, Within
Title
Measurements
OG0001
OG0011
OG0021
Basophils, Within, Below
Title
Measurements
OG0002
OG0010
OG0020
Basophils, Within, Within
Title
Measurements
OG00026
OG00133
OG00225
Basophils, Within, Above
Title
Measurements
OG0000
OG0010
OG0021
Eosinophils, Below, Below
Title
Measurements
OG0000
OG0012
OG0020
Eosinophils, Within, Below
Title
Measurements
OG0001
OG0010
OG0021
Eosinophils, Within, Within
Title
Measurements
OG00025
OG00130
OG00224
Eosinophils, Within, Above
Title
Measurements
OG0001
OG0011
OG0021
Eosinophils, Above, Within
Title
Measurements
OG0000
OG0010
OG0021
Eosinophils, Above, Above
Title
Measurements
OG0002
OG0011
OG0021
Erythrocytes, Within, Below
Title
Measurements
OG0000
OG0010
OG0021
Erythrocytes, Within, Within
Title
Measurements
OG00029
OG00132
OG00227
Erythrocytes, Above, Within
Title
Measurements
OG0000
OG0011
OG0020
Erythrocytes, Above, Above
Title
Measurements
OG0000
OG0011
OG0020
Haematocrit, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
Haematocrit, Within, Below
Title
Measurements
OG0000
OG0011
OG0020
Haematocrit, Within, Within
Title
Measurements
OG00029
OG00131
OG00228
Haematocrit, Above, Within
Title
Measurements
OG0000
OG0011
OG0020
Haemoglobin, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
Haemoglobin, Below, Within
Title
Measurements
OG0001
OG0010
OG0020
Haemoglobin, Within, Below
Title
Measurements
OG0000
OG0011
OG0020
Haemoglobin, Within, Within
Title
Measurements
OG00027
OG00130
OG00228
Haemoglobin, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
Haemoglobin, Above, Within
Title
Measurements
OG0000
OG0012
OG0020
Lymphocytes, Below, Below
Title
Measurements
OG0001
OG0011
OG0021
Lymphocytes, Below, Within
Title
Measurements
OG0002
OG0012
OG0020
Lymphocytes, Within, Below
Title
Measurements
OG0000
OG0013
OG0020
Lymphocytes, Within, Within
Title
Measurements
OG00025
OG00128
OG00227
Lymphocytes, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
Monocytes, Below, Below
Title
Measurements
OG0000
OG0010
OG0021
Monocytes, Below, Within
Title
Measurements
OG0001
OG0011
OG0021
Monocytes, Within, Within
Title
Measurements
OG00028
OG00130
OG00223
Monocytes, Within, Above
Title
Measurements
OG0000
OG0012
OG0020
Monocytes, Above, Within
Title
Measurements
OG0000
OG0011
OG0023
Neutrophils, Below, Below
Title
Measurements
OG0000
OG0010
OG0021
Neutrophils, Below, Within
Title
Measurements
OG0002
OG0013
OG0020
Neutrophils, Within, Below
Title
Measurements
OG0001
OG0010
OG0021
Neutrophils, Within, Within
Title
Measurements
OG00026
OG00126
OG00222
Neutrophils, Within, Above
Title
Measurements
OG0000
OG0012
OG0021
Neutrophils, Above, Within
Title
Measurements
OG0000
OG0012
OG0022
Neutrophils, Above, Above
Title
Measurements
OG0000
OG0011
OG0021
Platelets, Below, Within
Title
Measurements
OG0001
OG0010
OG0021
Platelets, Within, Below
Title
Measurements
OG0001
OG0010
OG0021
Platelets, Within, Within
Title
Measurements
OG00023
OG00129
OG00223
Platelets, Within, Above
Title
Measurements
OG0001
OG0012
OG0023
Platelets, Above, Within
Title
Measurements
OG0003
OG0010
OG0020
Platelets, Above, Above
Title
Measurements
OG0000
OG0013
OG0020
WBC, Below, Below
Title
Measurements
OG0001
OG0013
OG0021
WBC, Below, Within
Title
Measurements
OG0002
OG0012
OG0020
WBC, Within, Below
Title
Measurements
OG0001
OG0010
OG0021
WBC, Within, Within
Title
Measurements
OG00025
OG00126
OG00224
WBC, Within, Above
Title
Measurements
OG0000
OG0013
OG0020
WBC, Above, Within
Title
Measurements
OG0000
OG0010
OG0021
WBC, Above, Above
Title
Measurements
OG0000
OG0010
OG0021
OG000
10
OG00110
Title
Denominators
Categories
Pain, Vaccination at Day 1
Title
Measurements
OG0005
OG0012
Pain, Vaccination at Day 85
Title
Measurements
OG0004
OG0013
Erythema, Vaccination at Day 1
Title
Measurements
OG0000
OG0010
Erythema, Vaccination at Day 85
Title
Measurements
OG0000
OG0010
Swelling, Vaccination at Day 1
Title
Measurements
OG0000
OG0010
Swelling, Vaccination at Day 85
Title
Measurements
OG0000
OG0010
OG000
10
OG00110
Title
Denominators
Categories
Vaccination at Day 1
Title
Measurements
OG0000
OG0010
Vaccination at Day 85
Title
Measurements
OG0000
OG0010
OG00010
OG00110
Title
Denominators
Categories
Vaccination at Day 1
Title
Measurements
OG0002
OG0011
Vaccination at Day 85
Title
Measurements
OG0002
OG0012
Participants
OG00010
OG00110
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG00010
OG00110
Title
Denominators
Categories
ALT, Within, Below
Title
Measurements
OG0000
OG0011
ALT, Within, Within
Title
Measurements
OG00010
OG0019
AST, Within, Within
Title
Measurements
OG00010
OG00110
Creatinine, Below, Below
Title
Measurements
OG0006
OG0016
Creatinine, Below, Within
Title
Measurements
OG0001
OG0010
Creatinine, Within, Below
Title
Measurements
OG0000
OG0011
Creatinine, Within, Within
Title
Measurements
OG0003
OG0013
Basophils, Within, Within
Title
Measurements
OG00010
OG00110
Eosinophils, Within, Below
Title
Measurements
OG0000
OG0011
Eosinophils, Within, Within
Title
Measurements
OG00010
OG0019
Erythrocytes, Within, Within
Title
Measurements
OG00010
OG00110
Haematocrit, Within, Within
Title
Measurements
OG00010
OG00110
Haemoglobin, Within, Within
Title
Measurements
OG00010
OG00110
Lymphocytes, Below, Within
Title
Measurements
OG0000
OG0012
Lymphocytes, Within, Within
Title
Measurements
OG0009
OG0018
Lymphocytes, Above, Above
Title
Measurements
OG0001
OG0010
Monocytes, Within, Within
Title
Measurements
OG0009
OG0017
Monocytes, Within, Above
Title
Measurements
OG0000
OG0011
Monocytes, Above, Above
Title
Measurements
OG0001
OG0012
Neutrophils, Within, Within
Title
Measurements
OG0009
OG0019
Neutrophils, Within, Above
Title
Measurements
OG0001
OG0011
Platelets, Within, Within
Title
Measurements
OG00010
OG00110
WBC, Below, Within
Title
Measurements
OG0000
OG0011
WBC, Within, Within
Title
Measurements
OG0008
OG0018
WBC, Within, Above
Title
Measurements
OG0001
OG0011
WBC, Above, Above
Title
Measurements
OG0001
OG0010
Units
Counts
Participants
OG00010
OG00110
Title
Denominators
Categories
ALT, Within, Within
Title
Measurements
OG0009
OG00110
ALT, Within, Above
Title
Measurements
OG0001
OG0010
AST, Below, Within
Title
Measurements
OG0001
OG0010
AST, Within, Within
Title
Measurements
OG0008
OG00110
AST, Within, Above
Title
Measurements
OG0001
OG0010
Creatinine, Below, Below
Title
Measurements
OG0006
OG0014
Creatinine, Within, Below
Title
Measurements
OG0001
OG0012
Creatinine, Within, Within
Title
Measurements
OG0003
OG0014
Basophils, Within, Within
Title
Measurements
OG00010
OG00110
Eosinophils, Below, Within
Title
Measurements
OG0000
OG0011
Eosinophils, Within, Within
Title
Measurements
OG00010
OG0019
Erythrocytes, Within, Within
Title
Measurements
OG00010
OG00110
Haematocrit, Within, Within
Title
Measurements
OG00010
OG00110
Haemoglobin, Within, Within
Title
Measurements
OG00010
OG00110
Lymphocytes, Below, Within
Title
Measurements
OG0000
OG0011
Lymphocytes, Within, Within
Title
Measurements
OG0009
OG0019
Lymphocytes, Above, Above
Title
Measurements
OG0001
OG0010
Monocytes, Within, Within
Title
Measurements
OG0007
OG0019
Monocytes, Within, Above
Title
Measurements
OG0002
OG0011
Monocytes, Above, Within
Title
Measurements
OG0001
OG0010
Neutrophils, Within, Within
Title
Measurements
OG0008
OG00110
Neutrophils, Within, Above
Title
Measurements
OG0001
OG0010
Neutrophils, Above, Within
Title
Measurements
OG0001
OG0010
Platelets, Within, Within
Title
Measurements
OG0009
OG00110
Platelets, Within, Above
Title
Measurements
OG0001
OG0010
WBC, Within, Within
Title
Measurements
OG0008
OG00110
WBC, Within, Above
Title
Measurements
OG0001
OG0010
WBC, Above, Within
Title
Measurements
OG0001
OG0010
Units
Counts
Participants
OG00010
OG00110
OG00220
Title
Denominators
Categories
Erythema, Vaccination at Day 1
Title
Measurements
OG0001
OG0011
OG0020
Erythema, Vaccination at Day 85
Title
Measurements
OG0001
OG0010
OG0020
Pain, Vaccination at Day 1
Title
Measurements
OG0006
OG0012
OG0023
Pain, Vaccination at Day 85
Title
Measurements
OG0007
OG0012
OG0023
Swelling, Vaccination at Day 1
Title
Measurements
OG0001
OG0011
OG0020
Swelling, Vaccination at Day 85
Title
Measurements
OG0001
OG0010
OG0020
Units
Counts
Participants
OG00010
OG00110
OG00220
Title
Denominators
Categories
Vaccination at Day 1
Title
Measurements
OG0001
OG0011
OG0020
Vaccination at Day 85
Title
Measurements
OG0001
OG0012
OG0023
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
Units
Counts
Participants
OG00010
OG00110
OG00220
Title
Denominators
Categories
Vaccination at Day 1
Title
Measurements
OG0004
OG0013
OG0028
Vaccination at Day 85
Title
Measurements
OG0002
OG0010
OG0023
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
Units
Counts
Participants
OG00010
OG00110
OG00220
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG002
Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
Units
Counts
Participants
OG00010
OG00110
OG00220
Title
Denominators
Categories
ALT, Within, Within
Title
Measurements
OG0008
OG0019
OG00216
ALT, Within, Above
Title
Measurements
OG0000
OG0011
OG0021
ALT, Above, Within
Title
Measurements
OG0000
OG0010
OG0022
ALT, Above, Above
Title
Measurements
OG0002
OG0010
OG0021
AST, Within, Within
Title
Measurements
OG0008
OG00110
OG00220
AST, Above, Within
Title
Measurements
OG0002
OG0010
OG0020
Creatinine, Below, Below
Title
Measurements
OG0008
OG0019
OG00217
Creatinine, Below, Within
Title
Measurements
OG0001
OG0010
OG0020
Creatinine, Within, Below
Title
Measurements
OG0001
OG0011
OG0021
Creatinine, Within, Within
Title
Measurements
OG0000
OG0010
OG0021
Creatinine, Above, Within
Title
Measurements
OG0000
OG0010
OG0021
Basophils, Within, Below
Title
Measurements
OG0000
OG0010
OG0021
Basophils, Within, Within
Title
Measurements
OG0009
OG00110
OG00216
Basophils, Within, Above
Title
Measurements
OG0001
OG0010
OG0022
Basophils, Above, Within
Title
Measurements
OG0000
OG0010
OG0021
Eosinophils, Below, Within
Title
Measurements
OG0001
OG0010
OG0020
Eosinophils, Within, Below
Title
Measurements
OG0000
OG0010
OG0021
Eosinophils, Within, Within
Title
Measurements
OG0005
OG0016
OG00212
Eosinophils, Within, Above
Title
Measurements
OG0000
OG0010
OG0021
Eosinophils, Above, Within
Title
Measurements
OG0000
OG0011
OG0021
Eosinophils, Above, Above
Title
Measurements
OG0004
OG0013
OG0025
Erythrocytes, Within, Within
Title
Measurements
OG0008
OG0019
OG00212
Erythrocytes, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
Erythrocytes, Above, Within
Title
Measurements
OG0000
OG0011
OG0025
Erythrocytes, Above, Above
Title
Measurements
OG0001
OG0010
OG0023
Haematocrit, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
Haematocrit, Within, Within
Title
Measurements
OG0008
OG0017
OG00214
Haematocrit, Within, Above
Title
Measurements
OG0000
OG0010
OG0021
Haematocrit, Above, Within
Title
Measurements
OG0002
OG0012
OG0025
Haemoglobin, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
Haemoglobin, Below, Within
Title
Measurements
OG0001
OG0010
OG0020
Haemoglobin, Within, Below
Title
Measurements
OG0000
OG0010
OG0021
Haemoglobin, Within, Within
Title
Measurements
OG0007
OG0017
OG00218
Haemoglobin, Above, Within
Title
Measurements
OG0001
OG0012
OG0020
Haemoglobin, Above, Above
Title
Measurements
OG0001
OG0010
OG0021
Lymphocytes, Within, Within
Title
Measurements
OG0007
OG0017
OG0028
Lymphocytes, Within, Above
Title
Measurements
OG0001
OG0010
OG0022
Lymphocytes, Above, Within
Title
Measurements
OG0002
OG0011
OG0027
Lymphocytes, Above, Above
Title
Measurements
OG0000
OG0012
OG0023
Monocytes, Within, Within
Title
Measurements
OG0009
OG0018
OG00213
Monocytes, Within, Above
Title
Measurements
OG0001
OG0012
OG0023
Monocytes, Above, Within
Title
Measurements
OG0000
OG0010
OG0021
Monocytes, Above, Above
Title
Measurements
OG0000
OG0010
OG0023
Neutrophils, Below, Below
Title
Measurements
OG0000
OG0010
OG0021
Neutrophils, Below, Within
Title
Measurements
OG0002
OG0010
OG0022
Neutrophils, Within, Below
Title
Measurements
OG0002
OG0010
OG0021
Neutrophils, Within, Within
Title
Measurements
OG0006
OG00110
OG00216
Platelets, Within, Within
Title
Measurements
OG0001
OG0013
OG0024
Platelets, Within, Above
Title
Measurements
OG0005
OG0014
OG0022
Platelets, Above, Within
Title
Measurements
OG0000
OG0010
OG0024
Platelets, Above, Above
Title
Measurements
OG0004
OG0013
OG00210
WBC, Below, Within
Title
Measurements
OG0001
OG0010
OG0020
WBC, Within, Within
Title
Measurements
OG0009
OG00110
OG00219
WBC, Above, Above
Title
Measurements
OG0000
OG0010
OG0021
OG002
Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
Units
Counts
Participants
OG00010
OG00110
OG00220
Title
Denominators
Categories
ALT, Within, Within
Title
Measurements
OG0009
OG0015
OG00215
ALT, Within, Above
Title
Measurements
OG0000
OG0010
OG0022
ALT, Above, Within
Title
Measurements
OG0000
OG0012
OG0021
ALT, Above, Above
Title
Measurements
OG0001
OG0013
OG0022
AST, Within, Within
Title
Measurements
OG00010
OG00110
OG00219
AST, Within, Above
Title
Measurements
OG0000
OG0010
OG0021
Creatinine, Below, Below
Title
Measurements
OG00010
OG0018
OG00218
Creatinine, Within, Below
Title
Measurements
OG0000
OG0012
OG0022
Basophils, Within, Within
Title
Measurements
OG0009
OG0019
OG00220
Basophils, Above, Within
Title
Measurements
OG0001
OG0010
OG0020
Basophils, Above, Above
Title
Measurements
OG0000
OG0011
OG0020
Eosinophils, Within, Below
Title
Measurements
OG0001
OG0010
OG0020
Eosinophils, Within, Within
Title
Measurements
OG0006
OG0018
OG00216
Eosinophils, Within, Above
Title
Measurements
OG0001
OG0010
OG0021
Eosinophils, Above, Above
Title
Measurements
OG0002
OG0012
OG0023
Erythrocytes, Below, Within
Title
Measurements
OG0001
OG0010
OG0020
Erythrocytes, Within, Within
Title
Measurements
OG0007
OG0018
OG00217
Erythrocytes, Within, Above
Title
Measurements
OG0001
OG0010
OG0021
Erythrocytes, Above, Within
Title
Measurements
OG0000
OG0011
OG0020
Erythrocytes, Above, Above
Title
Measurements
OG0001
OG0011
OG0022
Haematocrit, Below, Below
Title
Measurements
OG0001
OG0010
OG0020
Haematocrit, Below, Within
Title
Measurements
OG0000
OG0010
OG0021
Haematocrit, Within, Within
Title
Measurements
OG0009
OG00110
OG00219
Haemoglobin, Below, Below
Title
Measurements
OG0001
OG0010
OG0021
Haemoglobin, Within, Below
Title
Measurements
OG0000
OG0010
OG0021
Haemoglobin, Within, Within
Title
Measurements
OG0009
OG0018
OG00218
Haemoglobin, Above, Within
Title
Measurements
OG0000
OG0012
OG0020
Lymphocytes, Within, Within
Title
Measurements
OG0007
OG0016
OG00214
Lymphocytes, Within, Above
Title
Measurements
OG0000
OG0010
OG0022
Lymphocytes, Above, Within
Title
Measurements
OG0003
OG0012
OG0023
Lymphocytes, Above, Above
Title
Measurements
OG0000
OG0012
OG0021
Monocytes, Below, Within
Title
Measurements
OG0000
OG0011
OG0020
Monocytes, Within, Within
Title
Measurements
OG0009
OG0017
OG00213
Monocytes, Within, Above
Title
Measurements
OG0001
OG0010
OG0022
Monocytes, Above, Within
Title
Measurements
OG0000
OG0010
OG0024
Monocytes, Above, Above
Title
Measurements
OG0000
OG0012
OG0021
Neutrophils, Below, Below
Title
Measurements
OG0002
OG0010
OG0020
Neutrophils, Below, Within
Title
Measurements
OG0001
OG0010
OG0021
Neutrophils, Within, Below
Title
Measurements
OG0000
OG0010
OG0021
Neutrophils, Within, Within
Title
Measurements
OG0005
OG00110
OG00218
Neutrophils, Within, Above
Title
Measurements
OG0002
OG0010
OG0020
Platelets, Within, Within
Title
Measurements
OG0003
OG0013
OG0027
Platelets, Within, Above
Title
Measurements
OG0001
OG0011
OG0025
Platelets, Above, Within
Title
Measurements
OG0002
OG0011
OG0022
Platelets, Above, Above
Title
Measurements
OG0004
OG0015
OG0026
WBC, Below, Within
Title
Measurements
OG0002
OG0010
OG0020
WBC, Within, Within
Title
Measurements
OG0007
OG00110
OG00219
WBC, Above, Above
Title
Measurements
OG0001
OG0010
OG0021
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00330
Title
Denominators
Categories
Erythema, Vaccination at Day 1
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00330
Title
Measurements
OG0000
OG0010
OG0023
OG003
Erythema, Vaccination at Day 85
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
Erythema, Vaccination at Day 253
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
Pain, Vaccination at Day 1
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00330
Pain, Vaccination at Day 85
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
Pain, Vaccination at Day 253
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
Swelling, Vaccination at Day 1
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00330
Swelling, Vaccination at Day 85
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
Swelling, Vaccination at Day 253
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00080
OG00179
OG00282
OG00381
Title
Denominators
Categories
Erythema, Vaccination at Day 1
ParticipantsOG00080
ParticipantsOG00179
ParticipantsOG00282
ParticipantsOG00381
Title
Measurements
OG00016
OG0019
OG00221
OG003
Erythema, Vaccination at Day 85
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00275
ParticipantsOG00374
Erythema, Vaccination at Day 253
ParticipantsOG00069
ParticipantsOG00171
ParticipantsOG00273
ParticipantsOG00371
Pain, Vaccination at Day 1
ParticipantsOG00080
ParticipantsOG00179
ParticipantsOG00282
ParticipantsOG00381
Pain, Vaccination at Day 85
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00275
ParticipantsOG00374
Pain, Vaccination at Day 253
ParticipantsOG00069
ParticipantsOG00171
ParticipantsOG00273
ParticipantsOG00371
Swelling, Vaccination at Day 1
ParticipantsOG00080
ParticipantsOG00179
ParticipantsOG00282
ParticipantsOG00381
Swelling, Vaccination at Day 85
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00275
ParticipantsOG00374
Swelling, Vaccination at Day 253
ParticipantsOG00069
ParticipantsOG00171
ParticipantsOG00273
ParticipantsOG00371
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00330
Title
Denominators
Categories
Vaccination at Day 1
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00330
Title
Measurements
OG0003
OG0011
OG0024
OG003
Vaccination at Day 85
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
Vaccination at Day 253
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00080
OG00179
OG00282
OG00381
Title
Denominators
Categories
Vaccination at Day 1
ParticipantsOG00080
ParticipantsOG00179
ParticipantsOG00282
ParticipantsOG00381
Title
Measurements
OG00027
OG00118
OG00223
OG003
Vaccination at Day 85
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00275
ParticipantsOG00374
Vaccination at Day 253
ParticipantsOG00069
ParticipantsOG00171
ParticipantsOG00273
ParticipantsOG00371
OG002
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00330
Title
Denominators
Categories
Vaccination at Day 1
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00330
Title
Measurements
OG0002
OG0013
OG0024
OG003
Vaccination at Day 85
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
Vaccination at Day 253
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00082
OG00181
OG00283
OG00382
Title
Denominators
Categories
Vaccination at Day 1
ParticipantsOG00082
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG00382
Title
Measurements
OG00035
OG00137
OG00234
OG003
Vaccination at Day 85
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00275
ParticipantsOG00374
Vaccination at Day 253
ParticipantsOG00069
ParticipantsOG00171
ParticipantsOG00273
ParticipantsOG00371
OG002
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00330
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00082
OG00181
OG00283
OG00382
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0024
OG0031
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
Units
Counts
Participants
OG00010
OG0019
OG00210
OG00330
Title
Denominators
Categories
ALT, Below, Within
Title
Measurements
OG0000
OG0010
OG0021
OG0030
ALT, Within, Within
Title
Measurements
OG00010
OG0019
OG0029
OG003
ALT, Within, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Within, Within
Title
Measurements
OG00010
OG0019
OG00210
OG003
Creatinine, Below, Below
Title
Measurements
OG00010
OG0019
OG00210
OG003
Basophils, Within, Within
Title
Measurements
OG0008
OG0010
OG00210
OG003
Basophils, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
OG003
Basophils, Above, Within
Title
Measurements
OG0001
OG0011
OG0020
OG003
Basophils, Above, Above
Title
Measurements
OG0000
OG0018
OG0020
OG003
Eosinophils, Within, Within
Title
Measurements
OG00010
OG0018
OG00210
OG003
Eosinophils, Above, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
Erythrocytes, Within, Within
Title
Measurements
OG0008
OG0019
OG0029
OG003
Erythrocytes, Within, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
Erythrocytes, Above, Within
Title
Measurements
OG0002
OG0010
OG0020
OG003
Erythrocytes, Above, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haematocrit, Below, Below
Title
Measurements
OG0001
OG0010
OG0020
OG003
Haematocrit, Below, Within
Title
Measurements
OG0001
OG0010
OG0021
OG003
Haematocrit, Within, Below
Title
Measurements
OG0001
OG0011
OG0020
OG003
Haematocrit, Within, Within
Title
Measurements
OG0007
OG0018
OG0028
OG003
Haematocrit, Within, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
Haematocrit, Above, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haematocrit, Above, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haemoglobin, Below, Below
Title
Measurements
OG0002
OG0010
OG0020
OG003
Haemoglobin, Below, Within
Title
Measurements
OG0001
OG0010
OG0021
OG003
Haemoglobin, Within, Below
Title
Measurements
OG0001
OG0013
OG0021
OG003
Haemoglobin, Within, Within
Title
Measurements
OG0006
OG0016
OG0026
OG003
Haemoglobin, Within, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
Haemoglobin, Above, Within
Title
Measurements
OG0000
OG0010
OG0021
OG003
Lymphocytes, Within, Within
Title
Measurements
OG0008
OG0015
OG0029
OG003
Lymphocytes, Within, Above
Title
Measurements
OG0001
OG0011
OG0021
OG003
Lymphocytes, Above, Within
Title
Measurements
OG0001
OG0011
OG0020
OG003
Lymphocytes, Above, Above
Title
Measurements
OG0000
OG0012
OG0020
OG003
Monocytes, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
OG003
Monocytes, Below, Within
Title
Measurements
OG0000
OG0010
OG0021
OG003
Monocytes, Within, Within
Title
Measurements
OG0007
OG0017
OG0026
OG003
Monocytes, Within, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
Monocytes, Above, Within
Title
Measurements
OG0000
OG0011
OG0022
OG003
Monocytes, Above, Above
Title
Measurements
OG0003
OG0010
OG0020
OG003
Neutrophils, Below, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils, Below, Within
Title
Measurements
OG0002
OG0010
OG0022
OG003
Neutrophils, Within, Below
Title
Measurements
OG0001
OG0010
OG0020
OG003
Neutrophils, Within, Within
Title
Measurements
OG0006
OG0019
OG0028
OG003
Neutrophils, Above, Within
Title
Measurements
OG0001
OG0010
OG0020
OG003
Platelets, Within, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelets, Within, Within
Title
Measurements
OG0001
OG0011
OG0022
OG003
Platelets, Within, Above
Title
Measurements
OG0002
OG0010
OG0024
OG003
Platelets, Above, Within
Title
Measurements
OG0003
OG0010
OG0020
OG003
Platelets, Above, Above
Title
Measurements
OG0004
OG0018
OG0024
OG003
WBC, Below, Within
Title
Measurements
OG0000
OG0010
OG0021
OG003
WBC, Within, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC, Within, Within
Title
Measurements
OG0008
OG0017
OG0029
OG003
WBC, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
OG003
WBC, Above, Within
Title
Measurements
OG0000
OG0011
OG0020
OG003
WBC, Above, Above
Title
Measurements
OG0001
OG0011
OG0020
OG003
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00079
OG00176
OG00282
OG00381
Title
Denominators
Categories
ALT, Within, Within
Title
Measurements
OG00077
OG00175
OG00279
OG00380
ALT, Within, Above
Title
Measurements
OG0001
OG0011
OG0022
OG003
ALT, Above, Within
Title
Measurements
OG0001
OG0010
OG0021
OG003
AST, Within, Within
Title
Measurements
OG00076
OG00176
OG00278
OG003
AST, Within, Above
Title
Measurements
OG0003
OG0010
OG0022
OG003
AST, Above, Within
Title
Measurements
OG0000
OG0010
OG0022
OG003
Creatinine, Below, Below
Title
Measurements
OG00079
OG00176
OG00281
OG003
Creatinine, Within, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
Potassium, Below, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium, Within, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
Potassium, Within, Within
Title
Measurements
OG00079
OG00176
OG00281
OG003
Potassium, Within, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium, Above, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium, Within, Within
Title
Measurements
OG00040
OG00135
OG00239
OG003
Sodium, Within, Above
Title
Measurements
OG00014
OG00120
OG00219
OG003
Sodium, Above, Within
Title
Measurements
OG0008
OG00111
OG00214
OG003
Sodium, Above, Above
Title
Measurements
OG00017
OG00110
OG00210
OG003
Urea, Below, Below
Title
Measurements
OG00031
OG00129
OG00236
OG003
Urea, Below, Within
Title
Measurements
OG00013
OG00113
OG00216
OG003
Urea, Within, Below
Title
Measurements
OG00010
OG00114
OG00211
OG003
Urea, Within, Within
Title
Measurements
OG00025
OG00120
OG00219
OG003
Basophils, Within, Within
Title
Measurements
OG00069
OG00170
OG00273
OG003
Basophils, Within, Above
Title
Measurements
OG0002
OG0012
OG0022
OG003
Basophils, Above, Within
Title
Measurements
OG0005
OG0014
OG0027
OG003
Basophils, Above, Above
Title
Measurements
OG0003
OG0010
OG0020
OG003
Eosinophils, Below, Within
Title
Measurements
OG0000
OG0012
OG0023
OG003
Eosinophils, Within, Below
Title
Measurements
OG0004
OG0013
OG0021
OG003
Eosinophils, Within, Within
Title
Measurements
OG00070
OG00165
OG00273
OG003
Eosinophils, Within, Above
Title
Measurements
OG0002
OG0011
OG0020
OG003
Eosinophils, Above, Within
Title
Measurements
OG0002
OG0013
OG0022
OG003
Eosinophils, Above, Above
Title
Measurements
OG0001
OG0012
OG0023
OG003
Erythrocytes, Below, Below
Title
Measurements
OG0001
OG0012
OG0021
OG003
Erythrocytes, Below, Within
Title
Measurements
OG0000
OG0011
OG0023
OG003
Erythrocytes, Within, Below
Title
Measurements
OG0001
OG0011
OG0021
OG003
Erythrocytes, Within, Within
Title
Measurements
OG00057
OG00145
OG00252
OG003
Erythrocytes, Within, Above
Title
Measurements
OG0004
OG0017
OG0027
OG003
Erythrocytes, Above, Within
Title
Measurements
OG0008
OG0015
OG0025
OG003
Erythrocytes, Above, Above
Title
Measurements
OG0008
OG00115
OG00213
OG003
Haematocrit, Below, Below
Title
Measurements
OG0004
OG0010
OG0020
OG003
Haematocrit, Below, Within
Title
Measurements
OG0001
OG0013
OG0022
OG003
Haematocrit, Within, Below
Title
Measurements
OG0002
OG0012
OG0022
OG003
Haematocrit, Within, Within
Title
Measurements
OG00062
OG00164
OG00273
OG003
Haematocrit, Within, Above
Title
Measurements
OG0000
OG0011
OG0021
OG003
Haematocrit, Above, Within
Title
Measurements
OG0009
OG0014
OG0022
OG003
Haematocrit, Above, Above
Title
Measurements
OG0001
OG0012
OG0022
OG003
Haemoglobin, Below, Below
Title
Measurements
OG0007
OG0013
OG0024
OG003
Haemoglobin, Below, Within
Title
Measurements
OG0005
OG0013
OG0024
OG003
Haemoglobin, Within, Below
Title
Measurements
OG0004
OG0019
OG0022
OG003
Haemoglobin, Within, Within
Title
Measurements
OG00058
OG00158
OG00268
OG003
Haemoglobin, Within, Above
Title
Measurements
OG0000
OG0011
OG0022
OG003
Haemoglobin, Above, Within
Title
Measurements
OG0004
OG0011
OG0020
OG003
Haemoglobin, Above, Above
Title
Measurements
OG0001
OG0011
OG0022
OG003
Lymphocytes, Below, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes, Within, Within
Title
Measurements
OG00051
OG00154
OG00258
OG003
Lymphocytes, Within, Above
Title
Measurements
OG0002
OG0013
OG0026
OG003
Lymphocytes, Above, Within
Title
Measurements
OG0007
OG0019
OG0028
OG003
Lymphocytes, Above, Above
Title
Measurements
OG00019
OG00110
OG00210
OG003
Monocytes, Within, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
Monocytes, Within, Within
Title
Measurements
OG00050
OG00153
OG00251
OG003
Monocytes, Within, Above
Title
Measurements
OG00023
OG00116
OG00219
OG003
Monocytes, Above, Within
Title
Measurements
OG0002
OG0011
OG0024
OG003
Monocytes, Above, Above
Title
Measurements
OG0004
OG0016
OG0028
OG003
Neutrophils, Below, Below
Title
Measurements
OG0007
OG0014
OG0027
OG003
Neutrophils, Below, Within
Title
Measurements
OG0007
OG0016
OG0026
OG003
Neutrophils, Within, Below
Title
Measurements
OG00012
OG00116
OG00212
OG003
Neutrophils, Within, Within
Title
Measurements
OG00052
OG00149
OG00256
OG003
Neutrophils, Within, Above
Title
Measurements
OG0000
OG0011
OG0021
OG003
Neutrophils, Above, Within
Title
Measurements
OG0001
OG0010
OG0020
OG003
Platelets, Below, Above
Title
Measurements
OG0001
OG0010
OG0020
OG003
Platelets, Within, Within
Title
Measurements
OG00012
OG00119
OG00214
OG003
Platelets, Within, Above
Title
Measurements
OG00011
OG00114
OG00212
OG003
Platelets, Above, Within
Title
Measurements
OG00014
OG00110
OG00215
OG003
Platelets, Above, Above
Title
Measurements
OG00041
OG00133
OG00241
OG003
WBC, Below, Below
Title
Measurements
OG0002
OG0011
OG0021
OG003
WBC, Below, Within
Title
Measurements
OG0000
OG0014
OG0024
OG003
WBC, Within, Below
Title
Measurements
OG0004
OG0016
OG0025
OG003
WBC, Within, Within
Title
Measurements
OG00054
OG00151
OG00255
OG003
WBC, Within, Above
Title
Measurements
OG0002
OG0015
OG0023
OG003
WBC, Above, Within
Title
Measurements
OG0009
OG0016
OG00210
OG003
WBC, Above, Above
Title
Measurements
OG0008
OG0013
OG0024
OG003
OG001
Stage 2 Infants Safety Cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
Units
Counts
Participants
OG0009
OG0018
OG00210
OG00328
Title
Denominators
Categories
ALT, Below, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Title
Measurements
OG0000
OG0010
OG0021
OG003
ALT, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
ALT, Above, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
AST, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
AST, Within, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
AST, Above, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Creatinine, Below, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Potassium, Within, Within
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00210
ParticipantsOG00310
Potassium, Within, Above
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00210
ParticipantsOG00310
Potassium, Above, Within
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00210
ParticipantsOG00310
Potassium, Above, Above
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00210
ParticipantsOG00310
Sodium, Within, Within
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00210
ParticipantsOG00310
Sodium, Within, Above
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00210
ParticipantsOG00310
Sodium, Above, Within
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00210
ParticipantsOG00310
Urea, Below, Below
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00210
ParticipantsOG00310
Urea, Below, Within
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00210
ParticipantsOG00310
Urea, Within, Below
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00210
ParticipantsOG00310
Urea, Within, Within
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00210
ParticipantsOG00310
Basophils, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Basophils, Within, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Basophils, Above, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Basophils, Above, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Eosinophils, Within, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Eosinophils, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Eosinophils, Within, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Eosinophils, Above, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Eosinophils, Above, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Erythrocytes, Below, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Erythrocytes, Within, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Erythrocytes, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Erythrocytes, Within, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Erythrocytes, Above, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Erythrocytes, Above, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haematocrit, Below, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haematocrit, Below, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haematocrit, Within, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haematocrit, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haematocrit, Within, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haematocrit, Above, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haematocrit, Above, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haemoglobin, Below, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haemoglobin, Below, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haemoglobin, Within, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haemoglobin, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Haemoglobin, Above, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Lymphocytes, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Lymphocytes, Within, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Lymphocytes, Above, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Lymphocytes, Above, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Monocytes, Below, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Monocytes, Within, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Monocytes, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Monocytes, Within, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Monocytes, Above, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Neutrophils, Below, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Neutrophils, Below, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Neutrophils, Below, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Neutrophils, Within, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Neutrophils, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Neutrophils, Within, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Platelets, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Platelets, Within, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Platelets, Above, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
Platelets, Above, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
WBC, Below, Below
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
WBC, Below, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
WBC, Within, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
WBC, Within, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
WBC, Above, Within
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
WBC, Above, Above
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00328
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00072
OG00172
OG00274
OG00373
Title
Denominators
Categories
ALT, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
OG0030
ALT, Below, Within
Title
Measurements
OG0000
OG0010
OG0021
OG003
ALT, Within, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Within, Within
Title
Measurements
OG00070
OG00168
OG00271
OG003
ALT, Within, Above
Title
Measurements
OG0002
OG0012
OG0020
OG003
ALT, Above, Within
Title
Measurements
OG0000
OG0011
OG0022
OG003
AST, Within, Within
Title
Measurements
OG00069
OG00171
OG00273
OG003
AST, Within, Above
Title
Measurements
OG0002
OG0011
OG0020
OG003
AST, Above, Within
Title
Measurements
OG0001
OG0010
OG0020
OG003
AST, Above, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
Creatinine, Below, Below
Title
Measurements
OG00072
OG00171
OG00274
OG003
Creatinine, Below, Within
Title
Measurements
OG0000
OG0011
OG0020
OG003
Potassium, Within, Within
Title
Measurements
OG00018
OG00116
OG00218
OG003
Potassium, Within, Above
Title
Measurements
OG00024
OG00126
OG00234
OG003
Potassium, Above, Within
Title
Measurements
OG0009
OG0018
OG0022
OG003
Potassium, Above, Above
Title
Measurements
OG00021
OG00122
OG00220
OG003
Sodium, Within, Within
Title
Measurements
OG00048
OG00153
OG00254
OG003
Sodium, Within, Above
Title
Measurements
OG0007
OG0015
OG0028
OG003
Sodium, Above, Within
Title
Measurements
OG00017
OG00111
OG00210
OG003
Sodium, Above, Above
Title
Measurements
OG0000
OG0013
OG0022
OG003
Urea, Below, Below
Title
Measurements
OG00027
OG00124
OG00232
OG003
Urea, Below, Within
Title
Measurements
OG0009
OG00112
OG0027
OG003
Urea, Below, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
Urea, Within, Below
Title
Measurements
OG00013
OG00115
OG00213
OG003
Urea, Within, Within
Title
Measurements
OG00023
OG00120
OG00222
OG003
Basophils, Below, Within
Title
Measurements
OG0000
OG0011
OG0020
OG003
Basophils, Within, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
Basophils, Within, Within
Title
Measurements
OG00058
OG00158
OG00264
OG003
Basophils, Within, Above
Title
Measurements
OG0008
OG0013
OG0027
OG003
Basophils, Above, Within
Title
Measurements
OG0005
OG0015
OG0022
OG003
Basophils, Above, Above
Title
Measurements
OG0001
OG0015
OG0021
OG003
Eosinophils, Below, Within
Title
Measurements
OG0000
OG0010
OG0021
OG003
Eosinophils, Within, Below
Title
Measurements
OG0001
OG0012
OG0021
OG003
Eosinophils, Within, Within
Title
Measurements
OG00061
OG00160
OG00262
OG003
Eosinophils, Within, Above
Title
Measurements
OG0002
OG0011
OG0022
OG003
Eosinophils, Above, Within
Title
Measurements
OG0006
OG0010
OG0021
OG003
Eosinophils, Above, Above
Title
Measurements
OG0002
OG0019
OG0027
OG003
Erythrocytes, Below, Within
Title
Measurements
OG0001
OG0011
OG0020
OG003
Erythrocytes, Within, Below
Title
Measurements
OG0000
OG0010
OG0022
OG003
Erythrocytes, Within, Within
Title
Measurements
OG00048
OG00145
OG00244
OG003
Erythrocytes, Within, Above
Title
Measurements
OG0005
OG0012
OG0025
OG003
Erythrocytes, Above, Within
Title
Measurements
OG0005
OG0013
OG0024
OG003
Erythrocytes, Above, Above
Title
Measurements
OG00013
OG00121
OG00219
OG003
Haematocrit, Below, Below
Title
Measurements
OG0001
OG0010
OG0021
OG003
Haematocrit, Below, Within
Title
Measurements
OG0001
OG0012
OG0020
OG003
Haematocrit, Within, Below
Title
Measurements
OG0003
OG0012
OG0022
OG003
Haematocrit, Within, Within
Title
Measurements
OG00060
OG00160
OG00257
OG003
Haematocrit, Within, Above
Title
Measurements
OG0004
OG0010
OG0025
OG003
Haematocrit, Above, Within
Title
Measurements
OG0000
OG0015
OG0023
OG003
Haematocrit, Above, Above
Title
Measurements
OG0003
OG0013
OG0026
OG003
Haemoglobin, Below, Below
Title
Measurements
OG0007
OG0017
OG0025
OG003
Haemoglobin, Below, Within
Title
Measurements
OG0002
OG0013
OG0021
OG003
Haemoglobin, Within, Below
Title
Measurements
OG0005
OG0012
OG0024
OG003
Haemoglobin, Within, Within
Title
Measurements
OG00054
OG00156
OG00259
OG003
Haemoglobin, Within, Above
Title
Measurements
OG0001
OG0011
OG0021
OG003
Haemoglobin, Above, Within
Title
Measurements
OG0002
OG0012
OG0021
OG003
Haemoglobin, Above, Above
Title
Measurements
OG0001
OG0011
OG0023
OG003
Lymphocytes, Within, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes, Within, Within
Title
Measurements
OG00038
OG00143
OG00244
OG003
Lymphocytes, Within, Above
Title
Measurements
OG00013
OG00111
OG00211
OG003
Lymphocytes, Above, Within
Title
Measurements
OG0006
OG0015
OG00210
OG003
Lymphocytes, Above, Above
Title
Measurements
OG00015
OG00113
OG0029
OG003
Monocytes, Below, Within
Title
Measurements
OG0001
OG0010
OG0020
OG003
Monocytes, Within, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
Monocytes, Within, Within
Title
Measurements
OG00052
OG00147
OG00260
OG003
Monocytes, Within, Above
Title
Measurements
OG0007
OG00115
OG0028
OG003
Monocytes, Above, Within
Title
Measurements
OG0009
OG0017
OG0023
OG003
Monocytes, Above, Above
Title
Measurements
OG0003
OG0013
OG0023
OG003
Neutrophils, Below, Below
Title
Measurements
OG0001
OG0011
OG0023
OG003
Neutrophils, Below, Within
Title
Measurements
OG0006
OG0017
OG00211
OG003
Neutrophils, Within, Below
Title
Measurements
OG0005
OG0017
OG0023
OG003
Neutrophils, Within, Within
Title
Measurements
OG00057
OG00153
OG00254
OG003
Neutrophils, Within, Above
Title
Measurements
OG0002
OG0012
OG0021
OG003
Neutrophils, Above, Within
Title
Measurements
OG0001
OG0012
OG0021
OG003
Neutrophils, Above, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
Platelets, Within, Within
Title
Measurements
OG0009
OG00115
OG00211
OG003
Platelets, Within, Above
Title
Measurements
OG00010
OG00114
OG00216
OG003
Platelets, Above, Below
Title
Measurements
OG0001
OG0010
OG0020
OG003
Platelets, Above, Within
Title
Measurements
OG0008
OG0016
OG0027
OG003
Platelets, Above, Above
Title
Measurements
OG00044
OG00137
OG00240
OG003
WBC, Below, Within
Title
Measurements
OG0003
OG0011
OG0022
OG003
WBC, Within, Below
Title
Measurements
OG0003
OG0011
OG0021
OG003
WBC, Within, Within
Title
Measurements
OG00047
OG00148
OG00256
OG003
WBC, Within, Above
Title
Measurements
OG0006
OG0019
OG0025
OG003
WBC, Above, Within
Title
Measurements
OG0005
OG0016
OG0023
OG003
WBC, Above, Above
Title
Measurements
OG0008
OG0017
OG0027
OG003
OG002
Stage 2 Infants Safety Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
Units
Counts
Participants
OG0009
OG0018
OG0029
OG00328
Title
Denominators
Categories
ALT, Within, Within
Title
Measurements
OG0009
OG0018
OG0029
OG00327
ALT, Above, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Within, Within
Title
Measurements
OG0009
OG0018
OG0029
OG003
Creatinine, Below, Below
Title
Measurements
OG0008
OG0018
OG0029
OG003
Creatinine, Within, Below
Title
Measurements
OG0001
OG0010
OG0020
OG003
Potassium, Within, Within
Title
Measurements
OG0001
OG0013
OG0023
OG003
Potassium, Within, Above
Title
Measurements
OG0003
OG0011
OG0020
OG003
Potassium, Above, Within
Title
Measurements
OG0001
OG0011
OG0023
OG003
Potassium, Above, Above
Title
Measurements
OG0004
OG0013
OG0023
OG003
Sodium, Within, Within
Title
Measurements
OG0004
OG0018
OG0026
OG003
Sodium, Within, Above
Title
Measurements
OG0002
OG0010
OG0020
OG003
Sodium, Above, Within
Title
Measurements
OG0001
OG0010
OG0023
OG003
Sodium, Above, Above
Title
Measurements
OG0002
OG0010
OG0020
OG003
Urea, Below, Below
Title
Measurements
OG0003
OG0012
OG0025
OG003
Urea, Below, Within
Title
Measurements
OG0003
OG0011
OG0021
OG003
Urea, Within, Below
Title
Measurements
OG0001
OG0011
OG0021
OG003
Urea, Within, Within
Title
Measurements
OG0002
OG0014
OG0022
OG003
Basophils, Within, Within
Title
Measurements
OG0005
OG0017
OG0028
OG003
Basophils, Within, Above
Title
Measurements
OG0002
OG0010
OG0020
OG003
Basophils, Above, Within
Title
Measurements
OG0002
OG0010
OG0021
OG003
Basophils, Above, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
Eosinophils, Below, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Eosinophils, Within, Within
Title
Measurements
OG0008
OG0017
OG0029
OG003
Eosinophils, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
OG003
Eosinophils, Above, Above
Title
Measurements
OG0000
OG0011
OG0020
OG003
Erythrocytes, Below, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
Erythrocytes, Within, Within
Title
Measurements
OG0006
OG0014
OG0027
OG003
Erythrocytes, Within, Above
Title
Measurements
OG0001
OG0011
OG0020
OG003
Erythrocytes, Above, Within
Title
Measurements
OG0001
OG0012
OG0022
OG003
Erythrocytes, Above, Above
Title
Measurements
OG0001
OG0011
OG0020
OG003
Haematocrit, Below, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haematocrit, Below, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haematocrit, Within, Within
Title
Measurements
OG0007
OG0016
OG0028
OG003
Haematocrit, Within, Above
Title
Measurements
OG0001
OG0011
OG0020
OG003
Haematocrit, Above, Within
Title
Measurements
OG0001
OG0011
OG0020
OG003
Haematocrit, Above, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
Haemoglobin, Below, Below
Title
Measurements
OG0000
OG0010
OG0022
OG003
Haemoglobin, Below, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haemoglobin, Within, Below
Title
Measurements
OG0001
OG0010
OG0020
OG003
Haemoglobin, Within, Within
Title
Measurements
OG0008
OG0018
OG0026
OG003
Haemoglobin, Within, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haemoglobin, Above, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haemoglobin, Above, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
Lymphocytes, Within, Within
Title
Measurements
OG0006
OG0016
OG0026
OG003
Lymphocytes, Within, Above
Title
Measurements
OG0002
OG0011
OG0020
OG003
Lymphocytes, Above, Within
Title
Measurements
OG0001
OG0011
OG0021
OG003
Lymphocytes, Above, Above
Title
Measurements
OG0000
OG0010
OG0022
OG003
Monocytes, Below, Within
Title
Measurements
OG0001
OG0010
OG0020
OG003
Monocytes, Within, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
Monocytes, Within, Within
Title
Measurements
OG0007
OG0018
OG0026
OG003
Monocytes, Within, Above
Title
Measurements
OG0001
OG0010
OG0022
OG003
Monocytes, Above, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Monocytes, Above, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils, Below, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils, Below, Within
Title
Measurements
OG0000
OG0011
OG0022
OG003
Neutrophils, Within, Below
Title
Measurements
OG0001
OG0010
OG0021
OG003
Neutrophils, Within, Within
Title
Measurements
OG0008
OG0015
OG0026
OG003
Neutrophils, Within, Above
Title
Measurements
OG0000
OG0012
OG0020
OG003
Platelets, Below, Within
Title
Measurements
OG0000
OG0011
OG0020
OG003
Platelets, Within, Within
Title
Measurements
OG0002
OG0012
OG0022
OG003
Platelets, Within, Above
Title
Measurements
OG0000
OG0010
OG0023
OG003
Platelets, Above, Within
Title
Measurements
OG0002
OG0011
OG0022
OG003
Platelets, Above, Above
Title
Measurements
OG0005
OG0014
OG0022
OG003
WBC, Below, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
WBC, Below, Within
Title
Measurements
OG0001
OG0012
OG0022
OG003
WBC, Within, Below
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC, Within, Within
Title
Measurements
OG0007
OG0014
OG0023
OG003
WBC, Within, Above
Title
Measurements
OG0001
OG0011
OG0022
OG003
WBC, Above, Within
Title
Measurements
OG0000
OG0011
OG0020
OG003
WBC, Above, Above
Title
Measurements
OG0000
OG0010
OG0021
OG003
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00069
OG00171
OG00273
OG00371
Title
Denominators
Categories
ALT, Below, Within
Title
Measurements
OG0001
OG0012
OG0021
OG0032
ALT, Within, Below
Title
Measurements
OG0002
OG0011
OG0020
OG003
ALT, Within, Within
Title
Measurements
OG00064
OG00167
OG00269
OG003
ALT, Within, Above
Title
Measurements
OG0001
OG0010
OG0023
OG003
ALT, Above, Within
Title
Measurements
OG0001
OG0011
OG0020
OG003
ALT, Above, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Within, Within
Title
Measurements
OG00068
OG00171
OG00271
OG003
AST, Within, Above
Title
Measurements
OG0001
OG0010
OG0021
OG003
AST, Above, Within
Title
Measurements
OG0000
OG0010
OG0021
OG003
AST, Above, Above
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine, Below, Below
Title
Measurements
OG00068
OG00170
OG00273
OG003
Creatinine, Below, Within
Title
Measurements
OG0000
OG0011
OG0020
OG003
Creatinine, Within, Below
Title
Measurements
OG0001
OG0010
OG0020
OG003
Potassium, Within, Within
Title
Measurements
OG00026
OG00128
OG00225
OG003
Potassium, Within, Above
Title
Measurements
OG00012
OG00118
OG00223
OG003
Potassium, Above, Within
Title
Measurements
OG00011
OG0018
OG0027
OG003
Potassium, Above, Above
Title
Measurements
OG00020
OG00117
OG00218
OG003
Sodium, Below, Within
Title
Measurements
OG0001
OG0012
OG0024
OG003
Sodium, Within, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
Sodium, Within, Within
Title
Measurements
OG00055
OG00161
OG00255
OG003
Sodium, Within, Above
Title
Measurements
OG0004
OG0014
OG0027
OG003
Sodium, Above, Within
Title
Measurements
OG0008
OG0013
OG0026
OG003
Sodium, Above, Above
Title
Measurements
OG0001
OG0011
OG0020
OG003
Urea, Below, Below
Title
Measurements
OG00018
OG00115
OG00216
OG003
Urea, Below, Within
Title
Measurements
OG00012
OG0016
OG00211
OG003
Urea, Within, Below
Title
Measurements
OG00010
OG00114
OG00214
OG003
Urea, Within, Within
Title
Measurements
OG00029
OG00136
OG00232
OG003
Basophils, Below, Within
Title
Measurements
OG0000
OG0010
OG0020
OG003
Basophils, Within, Within
Title
Measurements
OG00053
OG00154
OG00262
OG003
Basophils, Within, Above
Title
Measurements
OG0007
OG0018
OG0024
OG003
Basophils, Above, Within
Title
Measurements
OG0006
OG0016
OG0026
OG003
Basophils, Above, Above
Title
Measurements
OG0003
OG0013
OG0021
OG003
Eosinophils, Below, Within
Title
Measurements
OG0001
OG0011
OG0020
OG003
Eosinophils, Within, Below
Title
Measurements
OG0000
OG0012
OG0022
OG003
Eosinophils, Within, Within
Title
Measurements
OG00059
OG00158
OG00259
OG003
Eosinophils, Within, Above
Title
Measurements
OG0002
OG0014
OG0022
OG003
Eosinophils, Above, Within
Title
Measurements
OG0002
OG0011
OG0023
OG003
Eosinophils, Above, Above
Title
Measurements
OG0005
OG0015
OG0027
OG003
Erythrocytes, Below, Below
Title
Measurements
OG0000
OG0011
OG0020
OG003
Erythrocytes, Within, Within
Title
Measurements
OG00044
OG00139
OG00246
OG003
Erythrocytes, Within, Above
Title
Measurements
OG0004
OG0015
OG0025
OG003
Erythrocytes, Above, Within
Title
Measurements
OG0008
OG0012
OG0024
OG003
Erythrocytes, Above, Above
Title
Measurements
OG00013
OG00124
OG00218
OG003
Haematocrit, Below, Below
Title
Measurements
OG0002
OG0012
OG0020
OG003
Haematocrit, Below, Within
Title
Measurements
OG0001
OG0011
OG0020
OG003
Haematocrit, Within, Below
Title
Measurements
OG0000
OG0011
OG0020
OG003
Haematocrit, Within, Within
Title
Measurements
OG00055
OG00155
OG00256
OG003
Haematocrit, Within, Above
Title
Measurements
OG0001
OG0017
OG0029
OG003
Haematocrit, Above, Within
Title
Measurements
OG0005
OG0012
OG0022
OG003
Haematocrit, Above, Above
Title
Measurements
OG0005
OG0013
OG0026
OG003
Haemoglobin, Below, Below
Title
Measurements
OG0006
OG0014
OG0024
OG003
Haemoglobin, Below, Within
Title
Measurements
OG0003
OG0013
OG0020
OG003
Haemoglobin, Within, Below
Title
Measurements
OG0002
OG0015
OG0022
OG003
Haemoglobin, Within, Within
Title
Measurements
OG00053
OG00152
OG00257
OG003
Haemoglobin, Within, Above
Title
Measurements
OG0001
OG0012
OG0024
OG003
Haemoglobin, Above, Within
Title
Measurements
OG0002
OG0011
OG0024
OG003
Haemoglobin, Above, Above
Title
Measurements
OG0002
OG0014
OG0022
OG003
Lymphocytes, Within, Within
Title
Measurements
OG00043
OG00157
OG00258
OG003
Lymphocytes, Within, Above
Title
Measurements
OG00013
OG0016
OG0025
OG003
Lymphocytes, Above, Within
Title
Measurements
OG0004
OG0013
OG0028
OG003
Lymphocytes, Above, Above
Title
Measurements
OG0009
OG0015
OG0022
OG003
Monocytes, Below, Below
Title
Measurements
OG0001
OG0010
OG0020
OG003
Monocytes, Below, Within
Title
Measurements
OG0001
OG0010
OG0022
OG003
Monocytes, Within, Below
Title
Measurements
OG0001
OG0011
OG0020
OG003
Monocytes, Within, Within
Title
Measurements
OG00054
OG00161
OG00263
OG003
Monocytes, Within, Above
Title
Measurements
OG0007
OG0013
OG0025
OG003
Monocytes, Above, Within
Title
Measurements
OG0004
OG0014
OG0022
OG003
Monocytes, Above, Above
Title
Measurements
OG0001
OG0012
OG0021
OG003
Neutrophils, Below, Below
Title
Measurements
OG0005
OG0011
OG0020
OG003
Neutrophils, Below, Within
Title
Measurements
OG0004
OG0015
OG0029
OG003
Neutrophils, Within, Below
Title
Measurements
OG0003
OG0013
OG0025
OG003
Neutrophils, Within, Within
Title
Measurements
OG00055
OG00160
OG00258
OG003
Neutrophils, Within, Above
Title
Measurements
OG0001
OG0010
OG0020
OG003
Neutrophils, Above, Within
Title
Measurements
OG0001
OG0012
OG0021
OG003
Platelets, Below, Below
Title
Measurements
OG0000
OG0010
OG0021
OG003
Platelets, Below, Within
Title
Measurements
OG0000
OG0010
OG0021
OG003
Platelets, Within, Within
Title
Measurements
OG00017
OG00121
OG00219
OG003
Platelets, Within, Above
Title
Measurements
OG00010
OG00118
OG00217
OG003
Platelets, Above, Within
Title
Measurements
OG0008
OG0017
OG0028
OG003
Platelets, Above, Above
Title
Measurements
OG00034
OG00125
OG00227
OG003
WBC, Below, Below
Title
Measurements
OG0001
OG0010
OG0022
OG003
WBC, Below, Within
Title
Measurements
OG0004
OG0013
OG0026
OG003
WBC, Within, Below
Title
Measurements
OG0001
OG0012
OG0021
OG003
WBC, Within, Within
Title
Measurements
OG00044
OG00151
OG00253
OG003
WBC, Within, Above
Title
Measurements
OG0006
OG0016
OG0022
OG003
WBC, Above, Within
Title
Measurements
OG0004
OG0017
OG0026
OG003
WBC, Above, Above
Title
Measurements
OG0009
OG0012
OG0023
OG003
OG002
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
Units
Counts
Participants
OG00034
OG00134
OG00234
Title
Denominators
Categories
S sonnei Ab IgG, Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
Title
Measurements
OG00015.3(10.8 to 21.8)
OG0018.9(6.9 to 11.5)
OG00221.0(13.2 to 33.6)
S sonnei Ab IgG, Day 15
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S sonnei Ab IgG, Day 29
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S sonnei Ab IgG, Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S sonnei Ab IgG, Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S sonnei Ab IgG, Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
S sonnei Ab IgG, Day 113
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S sonnei Ab IgG, Day 197
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S sonnei Ab IgG, Day 113/197
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
S flexneri 1b Ab IgG, Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
Title
Measurements
OG000
S flexneri 1b Ab IgG, Day 15
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 1b Ab IgG, Day 29
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 1b Ab IgG, Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 1b Ab IgG, Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 1b Ab IgG, Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
S flexneri 1b Ab IgG, Day 113
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 1b Ab IgG, Day 197
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 1b Ab IgG, Day 113/197
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
S flexneri 2a Ab IgG, Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
Title
Measurements
OG000
S flexneri 2a Ab IgG, Day 15
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 2a Ab IgG, Day 29
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 2a Ab IgG, Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 2a Ab IgG, Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 2a Ab IgG, Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
S flexneri 2a Ab IgG, Day 113
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 2a Ab IgG, Day 197
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 2a Ab IgG, Day 113/197
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
S flexneri 3a Ab IgG, Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
Title
Measurements
OG000
S flexneri 3a Ab IgG, Day 15
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 3a Ab IgG, Day 29
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 3a Ab IgG, Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 3a Ab IgG, Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 3a Ab IgG, Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
S flexneri 3a Ab IgG, Day 113
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 3a Ab IgG, Day 197
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 3a Ab IgG, Day 113/197
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
10
OG00110
Title
Denominators
Categories
S sonnei Ab IgG, Day 1
Title
Measurements
OG000166.4(82.8 to 334.2)
OG001171.2(65.0 to 450.6)
S sonnei Ab IgG, Day 29
Title
Measurements
OG0003112.0(2181.6 to 4439.2)
OG001172.0(66.7 to 443.6)
S sonnei Ab IgG, Day 85
Title
Measurements
OG0002046.5(1372.1 to 3052.5)
OG001182.1(73.2 to 453.1)
S sonnei Ab IgG, Day 113
Title
Measurements
OG0001974.4(1288.5 to 3025.6)
OG001172.3(68.8 to 431.6)
S flexneri 1b Ab IgG, Day 1
Title
Measurements
OG000194.7(44.0 to 862.2)
OG001106.4(41.0 to 276.2)
S flexneri 1b Ab IgG, Day 29
Title
Measurements
OG000388.5(98.6 to 1531.3)
OG001103.3(40.2 to 265.8)
S flexneri 1b Ab IgG, Day 85
Title
Measurements
OG000328.0(84.8 to 1268.8)
OG001110.8(38.9 to 315.5)
S flexneri 1b Ab IgG, Day 113
Title
Measurements
OG000358.3(98.6 to 1301.7)
OG001107.2(37.5 to 306.1)
S flexneri 2a Ab IgG, Day 1
Title
Measurements
OG000192.3(93.7 to 394.6)
OG001155.8(70.7 to 343.6)
S flexneri 2a Ab IgG, Day 29
Title
Measurements
OG000563.0(269.1 to 1177.7)
OG001146.1(68.7 to 311.0)
S flexneri 2a Ab IgG, Day 85
Title
Measurements
OG000463.0(220.3 to 973.4)
OG001158.1(67.7 to 369.3)
S flexneri 2a Ab IgG, Day 113
Title
Measurements
OG000538.6(269.9 to 1074.7)
OG001154.0(68.5 to 346.2)
S flexneri 3a Ab IgG, Day 1
Title
Measurements
OG00084.8(34.5 to 208.8)
OG00161.3(19.6 to 192.0)
S flexneri 3a Ab IgG, Day 29
Title
Measurements
OG000212.8(89.9 to 503.6)
OG00157.4(18.2 to 181.5)
S flexneri 3a Ab IgG, Day 85
Title
Measurements
OG000174.4(75.1 to 405.3)
OG00162.3(16.7 to 233.3)
S flexneri 3a Ab IgG, Day 113
Title
Measurements
OG000225.4(103.2 to 492.7)
OG00161.6(16.7 to 226.8)
Units
Counts
Participants
OG00010
OG00110
OG00220
Title
Denominators
Categories
S sonnei Ab IgG, Day 1
Title
Measurements
OG00022.7(8.5 to 61.0)
OG00139.1(9.5 to 160.1)
OG00220.7(10.5 to 41.0)
S sonnei Ab IgG, Day 29
Title
Measurements
OG000899.0(122.7 to 6588.6)
OG001746.9(93.9 to 5940.9)
OG00219.3(10.4 to 35.8)
S sonnei Ab IgG, Day 85)
Title
Measurements
OG000702.7(125.7 to 3927.4)
OG001388.2(56.6 to 2663.4)
OG00224.7(11.1 to 54.7)
S sonnei Ab IgG, Day 113
Title
Measurements
OG0001163.2(289.8 to 4668.7)
OG001560.2(86.0 to 3651.0)
OG00240.2(15.9 to 101.6)
S flexneri 1b Ab IgG, Day 1
Title
Measurements
OG00028.6(6.6 to 123.1)
OG00138.4(7.0 to 211.4)
OG00237.0(16.4 to 83.3)
S flexneri 1b Ab IgG, Day 29
Title
Measurements
OG00074.0(23.3 to 234.8)
OG001119.4(27.2 to 525.1)
OG00233.4(13.6 to 81.7)
S flexneri 1b Ab IgG, Day 85
Title
Measurements
OG00039.3(10.7 to 144.5)
OG00165.4(13.1 to 326.7)
OG00234.5(15.0 to 79.6)
S flexneri 1b Ab IgG, Day 113
Title
Measurements
OG00066.7(20.5 to 217.0)
OG001100.3(21.6 to 466.4)
OG00231.9(14.0 to 72.4)
S flexneri 2a Ab IgG, Day 1
Title
Measurements
OG00024.5(5.1 to 117.9)
OG00121.0(4.7 to 93.0)
OG00230.9(12.4 to 77.3)
S flexneri 2a Ab IgG, Day 29
Title
Measurements
OG000219.2(65.6 to 732.9)
OG001193.5(76.2 to 491.6)
OG00230.6(12.7 to 74.2)
S flexneri 2a Ab IgG, Day 85
Title
Measurements
OG000101.2(28.7 to 356.9)
OG001103.8(36.3 to 297.0)
OG00232.1(14.2 to 72.5)
S flexneri 2a Ab IgG, Day 113
Title
Measurements
OG000267.3(101.0 to 707.4)
OG001290.0(115.0 to 731.3)
OG00229.5(13.8 to 63.2)
S flexneri 3a Ab IgG, Day 1
Title
Measurements
OG00014.2(4.5 to 44.7)
OG0018.5(3.5 to 20.6)
OG0027.6(3.0 to 19.8)
S flexneri 3a Ab IgG, Day 29
Title
Measurements
OG00030.7(10.7 to 87.9)
OG00122.0(7.6 to 63.7)
OG0026.2(2.5 to 15.2)
S flexneri 3a Ab IgG, Day 85
Title
Measurements
OG00017.8(5.9 to 53.4)
OG00114.1(4.9 to 40.3)
OG0026.2(2.7 to 14.2)
S flexneri 3a Ab IgG, Day 113
Title
Measurements
OG00032.1(12.3 to 84.2)
OG00126.1(10.2 to 66.7)
OG0027.0(3.2 to 15.6)
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00330
Title
Denominators
Categories
S sonnei Ab IgG, Day 1
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00330
Title
Measurements
OG0006.4(6.4 to 6.4)
OG0016.9(5.8 to 8.1)
OG0026.4(6.4 to 6.4)
OG003
S sonnei Ab IgG, Day 29
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
S sonnei Ab IgG, Day 85
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
S sonnei Ab IgG, Day 113
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00327
S sonnei Ab IgG, Day 253
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
S sonnei Ab IgG, Day 281
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00326
S flexneri 1b Ab IgG, Day 1
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00330
S flexneri 1b Ab IgG, Day 29
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
S flexneri 1b Ab IgG, Day 85
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
S flexneri 1b Ab IgG, Day 113
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00327
S flexneri 1b Ab IgG, Day 253
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
S flexneri 1b Ab IgG, Day 281
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00326
S flexneri 2a Ab IgG, Day 1
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00330
S flexneri 2a Ab IgG, Day 29
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
S flexneri 2a Ab IgG, Day 85
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
S flexneri 2a Ab IgG, Day 113
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00327
S flexneri 2a Ab IgG, Day 253
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
S flexneri 2a Ab IgG, Day 281
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00326
S flexneri 3a Ab IgG, Day 1
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00330
S flexneri 3a Ab IgG, Day 29
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
S flexneri 3a Ab IgG, Day 85
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
S flexneri 3a Ab IgG, Day 113
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00327
S flexneri 3a Ab IgG, Day 253
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
S flexneri 3a Ab IgG, Day 281
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00326
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00081
OG00181
OG00283
OG00382
Title
Denominators
Categories
S sonnei Ab IgG, Day 1
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG00382
Title
Measurements
OG00010.9(8.9 to 13.2)
OG0019.5(8.1 to 11.0)
OG00210.7(8.7 to 13.3)
OG003
S sonnei Ab IgG, Day 29
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00278
ParticipantsOG00380
S sonnei Ab IgG, Day 85
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00275
ParticipantsOG00374
S sonnei Ab IgG, Day 113
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00371
S sonnei Ab IgG, Day 253
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
S sonnei Ab IgG, Day 281
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG00369
S flexneri 1b Ab IgG, Day 1
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG00382
S flexneri 1b Ab IgG, Day 29
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00278
ParticipantsOG00380
S flexneri 1b Ab IgG, Day 85
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00275
ParticipantsOG00374
S flexneri 1b Ab IgG, Day 113
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00371
S flexneri 1b Ab IgG, Day 253
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
S flexneri 1b Ab IgG, Day 281
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG00369
S flexneri 2a Ab IgG, Day 1
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG00382
S flexneri 2a Ab IgG, Day 29
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00278
ParticipantsOG00380
S flexneri 2a Ab IgG, Day 85
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00275
ParticipantsOG00374
S flexneri 2a Ab IgG, Day 113
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00371
S flexneri 2a Ab IgG, Day 253
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
S flexneri 2a Ab IgG, Day 281
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG00369
S flexneri 3a Ab IgG, Day 1
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG00382
S flexneri 3a Ab IgG, Day 29
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00278
ParticipantsOG00380
S flexneri 3a Ab IgG, Day 85
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00275
ParticipantsOG00374
S flexneri 3a Ab IgG, Day 113
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00371
S flexneri 3a Ab IgG, Day 253
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
S flexneri 3a Ab IgG, Day 281
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG00369
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
Units
Counts
Participants
OG00034
OG00134
OG00234
Title
Denominators
Categories
Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
Title
Measurements
OG0001
OG0010
OG0025
Day 15
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
Day 29
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
Day 113
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Day 197
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
Day 113/197
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
10
OG00110
Title
Denominators
Categories
Day 1
Title
Measurements
OG0007
OG0015
Day 29
Title
Measurements
OG00010
OG0015
Day 85
Title
Measurements
OG00010
OG0016
Day 113
Title
Measurements
OG00010
OG0015
Units
Counts
Participants
OG00010
OG00110
OG00220
Title
Denominators
Categories
Day 1
Title
Measurements
OG0002
OG0014
OG0023
Day 29
Title
Measurements
OG0007
OG0016
OG0022
Day 85
Title
Measurements
OG0007
OG0016
OG0023
Day 113
Title
Measurements
OG0007
OG0016
OG0025
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00330
Title
Denominators
Categories
Day 1
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00330
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 29
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
Day 85
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
Day 113
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00327
Day 253
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
Day 281
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00326
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00081
OG00181
OG00283
OG00382
Title
Denominators
Categories
Day 1
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG00382
Title
Measurements
OG0001
OG0010
OG0022
OG003
Day 29
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00278
ParticipantsOG00380
Day 85
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00275
ParticipantsOG00374
Day 113
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00371
Day 253
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
Day 281
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG00369
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
Units
Counts
Participants
OG00034
OG00134
OG00234
Title
Denominators
Categories
Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
Title
Measurements
OG0001
OG0010
OG0022
Day 15
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
Day 29
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
Day 113
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Day 197
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
Day 113/197
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00228
Title
Measurements
OG002
10
OG00110
Title
Denominators
Categories
Day 1
Title
Measurements
OG0002
OG0013
Day 29
Title
Measurements
OG00010
OG0013
Day 85
Title
Measurements
OG00010
OG0013
Day 113
Title
Measurements
OG00010
OG0012
Units
Counts
Participants
OG00010
OG00110
OG00220
Title
Denominators
Categories
Day 1
Title
Measurements
OG0000
OG0011
OG0021
Day 29
Title
Measurements
OG0007
OG0016
OG0020
Day 85
Title
Measurements
OG0007
OG0016
OG0021
Day 113
Title
Measurements
OG0007
OG0016
OG0023
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00330
Title
Denominators
Categories
Day 1
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00330
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 29
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
Day 85
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
Day 113
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00327
Day 253
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
Day 281
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00326
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00081
OG00181
OG00283
OG00382
Title
Denominators
Categories
Day 1
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG00382
Title
Measurements
OG0001
OG0010
OG0022
OG003
Day 29
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00278
ParticipantsOG00380
Day 85
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00275
ParticipantsOG00374
Day 113
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00371
Day 253
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
Day 281
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG00369
OG002
Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169. All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
Units
Counts
Participants
OG00034
OG00134
OG00232
Title
Denominators
Categories
S sonnei Ab IgG, Day 15 compared to Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG00025
OG00127
OG0020
S sonnei Ab IgG, Day 29 compared to Day 1
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S sonnei Ab IgG, Day 85 compared to Day 1
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S sonnei Ab IgG, Day 113 compared to Day 1
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S sonnei Ab IgG, Day 113 compared to Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S sonnei Ab IgG, Day 169 compared to Day 1
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S sonnei Ab IgG, Day 85/169 compared to Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
S sonnei Ab IgG, Day 197 compared to Day 1
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S sonnei Ab IgG, Day 197 compared to Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S sonnei Ab IgG, Day 113/197 compared to Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
S sonnei Ab IgG, Day 113/197 compared to Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
S flexneri 1b Ab IgG, Day 15 compared to Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 1b Ab IgG, Day 29 compared to Day 1
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 1b Ab IgG, Day 85 compared to Day 1
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 1b Ab IgG, Day 113 compared to Day 1
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 1b Ab IgG, Day 113 compared to Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 1b Ab IgG, Day 169 compared to Day 1
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 1b Ab IgG, Day 85/169 compared to Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
S flexneri 1b Ab IgG, Day 197 compared to Day 1
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 1b Ab IgG, Day 197 compared to Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 1b Ab IgG, Day 113/197 compared to Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
S flexneri 1b Ab IgG, Day 113/197 compared to Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
S flexneri 2a Ab IgG, Day 15 compared to Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 2a Ab IgG, Day 29 compared to Day 1
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 2a Ab IgG, Day 85 compared to Day 1
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 2a Ab IgG, Day 113 compared to Day 1
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 2a Ab IgG, Day 113 compared to Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 2a Ab IgG, Day 169 compared to Day 1
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 2a Ab IgG, Day 85/169 compared to Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
S flexneri 2a Ab IgG, Day 197 compared to Day 1
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 2a Ab IgG, Day 197 compared to Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 2a Ab IgG, Day 113/197 compared to Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
S flexneri 2a Ab IgG, Day 113/197 compared to Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
S flexneri 3a Ab IgG, Day 15 compared to Day 1
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 3a Ab IgG, Day 29 compared to Day 1
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00232
Title
Measurements
OG000
S flexneri 3a Ab IgG, Day 85 compared to Day 1
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 3a Ab IgG, Day 169 compared to Day 1
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 3a Ab IgG, Day 85/169 compared to Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
S flexneri 3a Ab IgG, Day 113 compared to Day 1
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 3a Ab IgG, Day 113 compared to Day 85
ParticipantsOG00034
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
S flexneri 3a Ab IgG, Day 197 compared to Day 1
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 3a Ab IgG, Day 197 compared to Day 169
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG0020
Title
Measurements
OG001
S flexneri 3a Ab IgG, Day 113/197 compared to Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
S flexneri 3a Ab IgG, Day 113/197 compared to Day 85/169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00232
Title
Measurements
OG002
10
OG00110
Title
Denominators
Categories
S sonnei Ab IgG, Day 29 compared to Day 1
Title
Measurements
OG00010
OG0010
S sonnei Ab IgG, Day 85 compared to Day 1
Title
Measurements
OG00010
OG0010
S sonnei Ab IgG, Day 113 compared to Day 1
Title
Measurements
OG00010
OG0010
S Sonnei Ab IgG, Day 113 compared to Day 85
Title
Measurements
OG0000
OG0010
S flexneri 1b Ab IgG, Day 29 compared to Day 1
Title
Measurements
OG0002
OG0010
S flexneri 1b Ab IgG, Day 85 compared to Day 1
Title
Measurements
OG0001
OG0010
S flexneri 1b Ab IgG, Day 113 compared to Day 1
Title
Measurements
OG0001
OG0010
S flexneri 1b Ab IgG, Day 113 compared to Day 85
Title
Measurements
OG0000
OG0010
S flexneri 2a Ab IgG, Day 29 compared to Day 1
Title
Measurements
OG0003
OG0010
S flexneri 2a Ab IgG, Day 85 compared to Day 1
Title
Measurements
OG0002
OG0010
S flexneri 2a Ab IgG, Day 113 compared to Day 1
Title
Measurements
OG0003
OG0010
S flexneri 2a Ab IgG, Day 113 compared to Day 85
Title
Measurements
OG0000
OG0010
S flexneri 3a Ab IgG, Day 29 compared to Day 1
Title
Measurements
OG0004
OG0010
S flexneri 3a Ab IgG, Day 85 compared to Day 1
Title
Measurements
OG0002
OG0010
S flexneri 3a Ab IgG, Day 113 compared to Day 1
Title
Measurements
OG0003
OG0010
S flexneri 3a Ab IgG, Day 113 compared to Day 85
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG00010
OG00110
OG00220
Title
Denominators
Categories
S sonnei Ab IgG, Day 29 compared to Day 1
Title
Measurements
OG0007
OG0015
OG0021
S sonnei Ab IgG, Day 85 compared to Day 1
Title
Measurements
OG0007
OG0015
OG0023
S sonnei Ab IgG, Day 113 compared to Day 1
Title
Measurements
OG00010
OG0016
OG0025
S sonnei Ab IgG, Day 113 compared to Day 85
Title
Measurements
OG0001
OG0011
OG0023
S flexneri 1b Ab IgG, Day 29 compared to Day 1
Title
Measurements
OG0002
OG0014
OG0021
S flexneri 1b Ab IgG, Day 85 compared to Day 1
Title
Measurements
OG0000
OG0011
OG0021
S flexneri 1b Ab IgG, Day 113 compared to Day 1
Title
Measurements
OG0002
OG0013
OG0021
S flexneri 1b Ab IgG, Day 113 compared to Day 85
Title
Measurements
OG0000
OG0010
OG0021
S flexneri 2a Ab IgG, Day 29 compared to Day 1
Title
Measurements
OG0006
OG0016
OG0020
S flexneri 2a Ab IgG, Day 85 compared to Day 1
Title
Measurements
OG0003
OG0015
OG0021
S flexneri 2a Ab IgG, Day 113 compared to Day 1
Title
Measurements
OG0007
OG00110
OG0020
S flexneri 2a Ab IgG, Day 113 compared to Day 85
Title
Measurements
OG0003
OG0012
OG0020
S flexneri 3a Ab IgG, Day 29 compared to Day 1
Title
Measurements
OG0000
OG0013
OG0020
S flexneri 3a Ab IgG, Day 85 compared to Day 1
Title
Measurements
OG0000
OG0011
OG0020
S flexneri 3a Ab IgG, Day 113 compared to Day 1
Title
Measurements
OG0001
OG0013
OG0021
S flexneri 3a Ab IgG, Day 113 compared to Day 85
Title
Measurements
OG0000
OG0010
OG0021
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was administered on Day 29 and Day 281. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Safety Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was administered on Day 29 and Day 281.
Units
Counts
Participants
OG00010
OG0019
OG00210
OG00330
Title
Denominators
Categories
S sonnei Ab IgG, Day 29 compared to Day 1
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
Title
Measurements
OG0002
OG0010
OG0021
OG003
S sonnei Ab IgG, Day 85 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
S sonnei Ab IgG, Day 113 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00327
S sonnei Ab IgG, Day 113 compared to Day 85
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
S sonnei Ab IgG, Day 253 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
S sonnei Ab IgG, Day 281 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00326
S sonnei Ab IgG, Day 281 compared to Day 253
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
S flexneri 1b Ab IgG, Day 29 compared to Day 1
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
S flexneri 1b Ab IgG, Day 85 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
S flexneri 1b Ab IgG, Day 113 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00327
S flexneri 1b Ab IgG, Day 113 compared to Day 85
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG003
S flexneri 1b Ab IgG, Day 253 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
S flexneri 1b Ab IgG, Day 281 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00326
S flexneri 1b Ab IgG, Day 281 compared to Day 253
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG003
S flexneri 2a Ab IgG, Day 29 compared to Day 1
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
S flexneri 2a Ab IgG, Day 85 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
S flexneri 2a Ab IgG, Day 113 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00327
S flexneri 2a Ab IgG, Day 113 compared to Day 85
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG003
S flexneri 2a Ab IgG, Day 253 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
S flexneri 2a Ab IgG, Day 281 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00326
S flexneri 2a Ab IgG, Day 281 compared to Day 253
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG003
S flexneri 3a Ab IgG, Day 29 compared to Day 1
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00330
S flexneri 3a Ab IgG, Day 85 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00329
S flexneri 3a Ab IgG, Day 113 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00210
ParticipantsOG00327
S flexneri 3a Ab IgG, Day 113 compared to Day 85
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG003
S flexneri 3a Ab IgG, Day 253 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
S flexneri 3a Ab IgG, Day 281 compared to Day 1
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00326
S flexneri 3a Ab IgG, Day 281 compared to Day 253
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG003
OG002
Stage 2 Infants Dose-finding Cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00082
OG00181
OG00283
OG00382
Title
Denominators
Categories
S sonnei Ab IgG, Day 29 compared to Day 1
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00278
ParticipantsOG00380
Title
Measurements
OG00020
OG00130
OG00224
OG003
S sonnei Ab IgG, Day 85 compared to Day 1
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00275
ParticipantsOG00374
S sonnei Ab IgG, Day 113 compared to Day 1
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG00371
S sonnei Ab IgG, Day 113 compared to Day 85
ParticipantsOG00082
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG00382
S sonnei Ab IgG, Day 253 compared to Day 1
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
S sonnei Ab IgG, Day 281 compared to Day 1
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG00369
S sonnei Ab IgG, Day 281 compared to Day 253
ParticipantsOG00082
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG00382
S flexneri 1b Ab IgG, Day 29 compared to Day 1
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00278
ParticipantsOG00380
S flexneri 1b Ab IgG, Day 85 compared to Day 1
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00275
ParticipantsOG00374
S flexneri 1b Ab IgG, Day 113 compared to Day 1
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG003
S flexneri 1b Ab IgG, Day 113 compared to Day 85
ParticipantsOG00082
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG003
S flexneri 1b Ab IgG, Day 253 compared to Day 1
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG003
S flexneri 1b Ab IgG, Day 281 compared to Day 1
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG003
S flexneri 1b Ab IgG, Day 281 compared to Day 253
ParticipantsOG00082
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG003
S flexneri 2a Ab IgG, Day 29 compared to Day 1
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00278
ParticipantsOG003
S flexneri 2a Ab IgG, Day 85 compared to Day 1
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00275
ParticipantsOG003
S flexneri 2a Ab IgG, Day 113 compared to Day 1
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG003
S flexneri 2a Ab IgG, Day 113 compared to Day 85
ParticipantsOG00082
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG003
S flexneri 2a Ab IgG, Day 253 compared to Day 1
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG003
S flexneri 2a Ab IgG, Day 281 compared to Day 1
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG003
S flexneri 2a Ab IgG, Day 281 compared to Day 253
ParticipantsOG00082
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG003
S flexneri 3a Ab IgG, Day 29 compared to Day 1
ParticipantsOG00076
ParticipantsOG00174
ParticipantsOG00278
ParticipantsOG003
S flexneri 3a Ab IgG, Day 85 compared to Day 1
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00275
ParticipantsOG003
S flexneri 3a Ab IgG, Day 113 compared to Day 1
ParticipantsOG00070
ParticipantsOG00169
ParticipantsOG00273
ParticipantsOG003
S flexneri 3a Ab IgG, Day 113 compared to Day 85
ParticipantsOG00082
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG003
S flexneri 3a Ab IgG, Day 253 compared to Day 1
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG003
S flexneri 3a Ab IgG, Day 281 compared to Day 1
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG003
S flexneri 3a Ab IgG, Day 281 compared to Day 253
ParticipantsOG00082
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG003
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00081
OG00181
OG00283
OG00382
Title
Denominators
Categories
Day 1
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG00382
Title
Measurements
OG00026.2(23.8 to 28.9)
OG00125.4(24.6 to 26.1)
OG00225(25 to 25)
OG003
Day 281
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG00369
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00081
OG00181
OG00283
OG00382
Title
Denominators
Categories
Day 1
ParticipantsOG00081
ParticipantsOG00181
ParticipantsOG00283
ParticipantsOG00382
Title
Measurements
OG0001.2(1 to 1.4)
OG0011(1 to 1)
OG0021.1(1 to 1.3)
OG003
Day 281
ParticipantsOG00066
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG00369
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.
Units
Counts
Participants
OG00066
OG00164
OG00271
OG00369
Title
Denominators
Categories
>= 150 mIU/mL, Day 281
Title
Measurements
OG00066
OG00164
OG00271
OG00368
>= 200 mIU/mL, Day 281
Title
Measurements
OG00066
OG00164
OG00271
OG003
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
OG003
Stage 2 Infants Dose-finding Cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253. MR-VAC was co-administered on Day 1 and Day 253. This cohort was created to identify the preferred dose among low, medium and high doses.