A Study on the Safety, Effectiveness and Immune Response... | NCT04886154 | Trialant
NCT04886154
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
May 31, 2025Actual
Enrollment
1,440Actual
Phase
Phase 1Phase 2
Conditions
Infections, Meningococcal
Interventions
MenABCWY-2Gen low dose vaccine
MenABCWY-2Gen high dose vaccine
Placebo
MenB vaccine
MenACWY vaccine
Countries
United States
Australia
Belgium
Brazil
Finland
Poland
Sweden
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT04886154
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
212458
Secondary IDs
ID
Type
Description
Link
2020-004741-37
EudraCT Number
Brief Title
A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults
Official Title
A Phase I/II, Randomised, Controlled Study to Assess the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Adults (Phase I) and to Healthy Adolescents and Adults (Phase II)
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
May 2025
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
Jun 14, 2021Actual
Primary Completion Date
Feb 2, 2024Actual
Completion Date
Feb 2, 2024Actual
First Submitted Date
May 10, 2021
First Submission Date that Met QC Criteria
May 10, 2021
First Posted Date
May 13, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jan 31, 2025
Results First Submitted that Met QC Criteria
Jan 31, 2025
Results First Posted Date
Feb 26, 2025Actual
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
May 14, 2025
Last Update Posted Date
May 31, 2025Actual
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
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to assess the safety, effectiveness, and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of this study was conducted in healthy adults in a dose-escalating fashion with 2 formulations of the investigational MenABCWY-2Gen vaccine and served as a safety lead-in to the Phase II study. The Phase II part of the study was conducted in 2 parts: The 'formulation and schedule-finding' part followed in healthy adolescents and young adults and was designed to select the vaccine formulation and the schedule to be tested in Phase III. The 'blood sourcing' part was conducted in healthy adults in order to collect sufficient serum samples for the development of assays to be used in the MenABCWY-2Gen vaccine clinical development program.
Detailed Description
Not provided
Conditions Module
Conditions
Infections, Meningococcal
Keywords
Bexsero
Menveo
Boostrix
MenABCWY-2Gen
Effectiveness
Safety
Invasive Meningococcal Disease
Adolescents and Adults
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
1,440Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ABCWY low dose Group
Experimental
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
Combination Product: Placebo
ABCWY high dose Group
Experimental
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
Combination Product: MenABCWY-2Gen high dose vaccine
Placebo high dose Group
Placebo Comparator
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
Combination Product: Placebo
ABCWY low dose_06 Group
Experimental
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MenABCWY-2Gen low dose vaccine
Combination Product
MenABCWY-2Gen low dose vaccine is administered intramuscularly as 2 doses to participants in the ABCWY low dose Group in study Phase I, ABCWY low dose_06 Group and ABCWY low dose_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY low dose_01 Group, ABCWY low doseS_02 Group and ABCWY low doseS_06 Group in study Phase II (Sourcing).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in)
The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in)
The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
During the 7 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With Solicited Systemic Events in Study Phase I (Safety Lead-in)
The solicited systemic events include fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.
During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Systemic Events in Study Phase I (Safety Lead-in)
The solicited systemic events include fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.
During the 7 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With Any Unsolicited Adverse Events (AEs), Including All Serious Adverse Events (SAEs), AEs Leading to Withdrawal and AEs of Special Interest (AESIs) in Study Phase I (Safety Lead-in)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Classified by Percentages of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Participant in Study Phase II (Formulation and Schedule-finding)
The percentages of strains killed measured by enc-hSBA against a randomly selected panel of strains and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method is calculated in all groups at 1 month after the last vaccination of MenABCWY-2Gen (low and high dose) vaccine administered at 0,2 and 0,6-months schedule and of the MenB vaccine administered at 0,6-months schedule.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
All inclusion criteria are applicable for both study phases, except where specified otherwise.
Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the eDiaries, return for follow-up visits).
Written or witnessed/thumb printed informed consent obtained from the participant or /parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
Written informed assent obtained from the participant (if applicable) prior to performing any study specific procedure.
Phase I only: A male or female between, and including, 18 and 40 years of age (i.e. 40 years + 364 days) at the time of the first study intervention administration.
Phase II (Formulation and Schedule-finding) only: A male or female between, and including, 10 and 25 years of age (i.e. 25 years + 364 days) at the time of the first study intervention administration.
Phase II (Sourcing) only: A male or female between, and including, 18 and 50 years of age (i.e. 50 years + 364 days) at the time of the first study intervention administration.
Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine can participate in the study, if they have received it at least 4 years prior to informed consent and assent as applicable (with the exception of meningococcal C vaccination, if the last dose of MenC was received at ≤24 months of age).
Healthy participants as established by medical history and clinical examination before entering into the study.
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.
Exclusion Criteria:
Medical conditions
Current or previous, confirmed or suspected disease caused by N. meningitidis.
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrolment.
Progressive, unstable or uncontrolled clinical conditions.
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
Are obese at enrolment (e.g. for participants from 20 years of age a body mass index (BMI) ≥ 30 kg/m2, for participants up to 19 years of age a BMI ≥ 95th percentile for age and gender or as applicable per country recommendations).
Any neuroinflammatory (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures). History of febrile convulsions should not lead to exclusion.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study.
Abnormal function or modification of the immune system resulting from:
Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 3 months prior to study vaccination until the last blood sampling visit for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation and Schedule-finding). This will mean prednisone equivalent ≥20 mg/day for adult participants/ ≥0.5 mg/kg/day with maximum of 20 mg/day for paediatric participants. Inhaled and topical steroids are allowed.
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Prior/Concomitant therapy
Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period.
Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention(s) or planned administration until the last blood sampling visit for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation and Schedule-finding).
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 study intervention dose(s) until the last blood sampling visit for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation and Schedule-finding). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants/ ≥0.5 mg/kg/day with maximum of 20 mg/day for paediatric participants. Inhaled and topical steroids are allowed.
Prior/Concurrent clinical study experience
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
Other exclusions
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
History of /current chronic alcohol abuse and/or drug abuse as determined by the investigator.
Any study personnel or immediate dependents, family, or household member.
Phase II (Formulation and Schedule-finding): Child in care.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
10 Years
Maximum Age
50 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Colorado Springs
Colorado
80922
United States
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
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.
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Out of 1440 participants enrolled, 3 participants from Phase II (Formulation and Schedule-finding) did not receive vaccination as they did not meet the eligibility criteria, therefore only 1437 participants were included in the Exposed Set and started the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
FG001
Placebo Low Dose Group
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 11, 2022
Jan 31, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
Data will be collected in an observer-blind manner.
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Combination Product: MenABCWY-2Gen high dose vaccine
Combination Product: Placebo
ABCWY high dose_02 Group
Experimental
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
Combination Product: MenABCWY-2Gen high dose vaccine
Combination Product: Placebo
Control Group
Active Comparator
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Combination Product: MenB vaccine
Biological: MenACWY vaccine
ABCWY low dose_01 Group
Experimental
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
Combination Product: MenABCWY-2Gen high dose vaccine
ABCWY low doseS_02 Group
Experimental
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
Combination Product: MenABCWY-2Gen high dose vaccine
ABCWY low doseS_06 Group
Experimental
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
Combination Product: MenABCWY-2Gen high dose vaccine
ABCWY low dose Group
ABCWY low doseS_02 Group
ABCWY low doseS_06 Group
ABCWY low dose_01 Group
ABCWY low dose_02 Group
ABCWY low dose_06 Group
MenABCWY-2Gen high dose vaccine
Combination Product
MenABCWY-2Gen high dose vaccine is administered intramuscularly 2 doses to participants in the ABCWY high dose Group in study Phase I, ABCWY high dose_06 Group and ABCWY high dose_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY high dose_01 Group, ABCWY high doseS_02 Group and ABCWY high doseS_06 Group in study Phase II (Sourcing).
ABCWY high dose Group
ABCWY high doseS_02 Group
ABCWY high doseS_06 Group
ABCWY high dose_01 Group
ABCWY high dose_02 Group
ABCWY high dose_06 Group
Placebo
Combination Product
Placebo is administered intramuscularly as 2 doses to participants in the Placebo low dose Group, Placebo high dose Group in study Phase I and as 1 dose to participants in the ABCWY low dose_06 Group, ABCWY low dose_02 Group, ABCWY high dose_06 Group, ABCWY high dose_02 Group in study Phase II (Formulation and Schedule-finding).
ABCWY high dose_02 Group
ABCWY high dose_06 Group
ABCWY low dose_02 Group
ABCWY low dose_06 Group
Placebo high dose Group
Placebo low dose Group
NaCl, saline solution
MenB vaccine
Combination Product
MenB vaccine is administered intramuscularly as 2 doses in a 0,6-months schedule to participants in the Control Group in study Phase II (Formulation and Schedule-finding).
Control Group
GSK's meningococcal group B vaccine, Bexsero
MenACWY vaccine
Biological
MenACWY vaccine is administered intramuscularly as 1 dose to participants in the Control Group in study Phase II (Formulation and Schedule-finding).
Control Group
GSK's combined meningococcal groups A, C, Y and W-135 conjugate vaccine, Menveo
During the 30 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Any Unsolicited AEs, Including All SAEs, AEs Leading to Withdrawal and AESIs in Study Phase I (Safety Lead-in)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
During the 30 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase I (Safety Lead-in)
A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Throughout the Phase 1 study period (Day 1 through Day 211)
Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values, in Study Phase I (Safety Lead-in)
The safety laboratory data included haematological parameters (basophils, eosinophils, Erythrocytes, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine) Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
At Day 8 (7 days after the first vaccination)
Number of Participants With Clinically Significant Haematological and Biochemical Laboratory Values, in Study Phase I (Safety Lead-in)
Clinical laboratory testing included hematological and biochemical laboratory values. Any abnormal laboratory test result (e.g., in hematology or clinical chemistry) that was deemed clinically significant by the investigator's medical and scientific judgment, and not related to an underlying disease, was reported as an unsolicited adverse event (AE) unless it was considered by the investigator to be more severe than expected for the participant's condition. The safety laboratory data included hematological parameters (basophils, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, monocytes, platelets, and neutrophils) and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], and creatinine).
At Day 8 (7 days after the first vaccination)
Percentage of Blood Samples With Bactericidal Serum Activity Using Enc-hSBA Against a Panel of 110 Randomly Selected Endemic US N. Meningitidis Serogroup B Invasive Disease Strains at Study Phase II (Formulation and Schedule-finding)
The effectiveness of the MenABCWY-2Gen (low & high dose) vaccine when administered at 0,2- or 0,6-months schedule compared to MenB vaccine administered at 0,6-months schedule, against a panel of 110 randomly selected endemic N. meningitidis serogroup B strains is measured in terms of percentage of samples with bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.
At Day 211 (1 month after the last vaccination)
Number of Participants With a 4-fold Rise in hSBA Titers Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune response to the MenABCWY-2Gen (low and high dose) vaccine when administered at 0,2- or 0,6-months schedule compared to MenACWY vaccine (single dose), relative to day 1 in the ABCWY and control groups (0, 6 month schedule) and day 31 in ABCWY (0, 2 month schedule) is measured in terms of number of participants achieving a 4-fold rise in hSBA titers against serogroups A, C, W and Y. The 4-fold rise is defined as: -a post-vaccination hSBA titer ≥ 16 for participants with a pre-vaccination hSBA titer < 4, -a post-vaccination hSBA titer ≥ 4 times the lower limit of quantitation (LLOQ) for participants with a pre-vaccination hSBA titer ≥LOD but \
At Day 211 for ABCWY groups (1 month after the last MenABCWY-2Gen vaccination) and at Day 31 for Control group (1 month after the last MenACWY vaccination)
Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
During the 7 days (including the day of vaccination) following vaccination at Day 121
Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
During the 7 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
During the 7 days (including the day of vaccination) following vaccination at Day 121
Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
During the 7 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
During the 30 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
During the 30 days (including the day of vaccination) following vaccination at Day 121
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
During the 30 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Formulation and Schedule-Finding)
A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Throughout the Phase II FSF study period (Day 1 through Day 541)
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
During the 7 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
During the 7 days (including the day of vaccination) following vaccination at Day 61
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
During the 7 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
During the 7 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
During the 7 days (including the day of vaccination) following vaccination at Day 61
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
During the 7 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
During the 30 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
During the 30 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
During the 30 days (including the day of vaccination) following vaccination at Day 61
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
During the 30 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)
A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Throughout the study period (Day 1 through Day 211)
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)
A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Throughout the study period (Day 1 through Day 241)
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)
A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Throughout the study period (Day 1 through Day 361)
At Day 211 (1 month after the last vaccination)
Number of Participants With hSBA Titers ≥ LLOQ for Each and All Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
The immune response to MenABCWY-2Gen (low and high dose) administered at 0,2 and 0,6-months schedule and MenB vaccine administered at 0,6-months schedule is evaluated by measuring bactericidal activity using a qualified AO hSBA against a standard panel of serogroup B indicator strains.
At Day 1 in ABCWY (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2-months) and Day 211 in all study groups
Number of Participants With 4-fold Rise in hSBA Titers Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
The immune response to MenABCWY-2Gen (low and high dose) vaccine when administered at 0,2- or 0,6-months schedule and to MenB vaccine administered at 0,6-months schedule, relative to day 1 in ABCWY (0,6 month schedule) and control groups and day 31 in ABCWY (0,2 month schedule) is measured in terms of number of participants achieving a 4-fold rise in hSBA titers against serogroup B indicator strains. The 4-fold rise is defined as: -a post-vaccination hSBA titer ≥ 16 for participants with a pre-vaccination hSBA titre < 4, -a post-vaccination hSBA titer ≥ 4 times the LLOQ for participants with a pre-vaccination hSBA titer ≥LOD but \
At Day 211 (1 month after the last vaccination)
hSBA Geometric Mean Titers (GMTs) Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
For each B strains, the GMTs are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
At Day 1 in ABCWY groups (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2-months) and Day 211 in all study groups
hSBA Geometric Mean Ratios (GMRs) Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
For each B strains, the GMRs (post-vaccination/ Baseline) are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
At Day 211 in all study groups versus Day 1 in ABCWY (0,6-months) and Control groups and Day 31 in ABCWY groups (0,2-months)
Number of Participants With hSBA Titers ≥ LLOQ for Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The number of participants with hSBA titers ≥ LLOQ and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method are calculated. Baseline (pre-vaccination) was evaluated at Day 1 for 0,6 schedules and Control, at Month 1 for 0,2 schedules. Post vaccination was evaluated at Month 7 for all MenABCWY groups, at Month 1 for Control group.
Day 1 in ABCWY (0,6 Months) & Control; Day 31 pre-vaccination in ABCWY (0,2 Months); Day 31 post-first MenABCWY-2Gen in ABCWY (0,6 Months); Day 211 post-last MenABCWY-2Gen in all ABCWY; Day 31 post-MenACWY in Control
Number of Participants With a 4-fold Rise in hSBA Titers Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune response to the MenABCWY-2Gen (low and high dose) vaccine when administered at 0,6-months schedule, relative to day 1 was measured in terms of percentage of participants achieving a 4-fold rise in hSBA titers against serogroups A, C, W and Y. Serum bactericidal activity against MenACWY were determined by using a validated AO hSBA. The 4-fold rise is defined as: -a post-vaccination hSBA titre ≥ 16 for participants with a pre-vaccination hSBA titre < 4, -a post-vaccination hSBA titre ≥ 4 times the LLOQ for participants with a pre-vaccination hSBA titre ≥ LOD but < LLOQ, and. -a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ.
At Day 31 (1 month after the first MenABCWY-2Gen vaccination) in ABCWY (0,6-months) groups
hSBA GMTs Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune response to the MenABCWY-2Gen (low and high dose) vaccine (0,2- and 0,6-months schedule) and MenACWY vaccine (single dose) was evaluated by hSBA titers which are logarithmically transformed (base10) to fulfil the normal distribution assumption. For each serogroup A, C, W and Y, the GMTs are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
Day 1 in ABCWY (0,6 Months) & Control; Day 31 pre-vaccination in ABCWY (0,2 Months); Day 31 post-first MenABCWY-2Gen in ABCWY (0,6 Months); Day 211 post-last MenABCWY-2Gen in all ABCWY; Day 31 post-MenACWY in Control
hSBA GMRs Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
For each serogroup A, C, W and Y, the GMRs (post-vaccination/ Day 1 (Month 0)) are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
At Day 31 [for ABCWY (0,6-months) and Control group compared to Day 1 (Baseline)], at Day 211 [for ABCWY (0,6-months) groups compared to Day 1 (baseline) and for ABCWY (0,2-months) groups compared to Day 31]
Immunoglobulin G (IgG) Antibodies Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune responses to MenABCWY-2Gen (low and high dose) and MenACWY vaccines are evaluated by measuring the total IgG in terms of electrochemiluminescence-based (ECL) multiplex assay Geometric Mean Concentrations (GMCs).
Day 1 in ABCWY (0,6 Months) & Control; Day 31 pre-vaccination in ABCWY (0,2 Months); Day 31 post-first MenABCWY-2Gen in ABCWY (0,6 Months); Day 211 post-last MenABCWY-2Gen in all ABCWY; Day 31 post-MenACWY in Control
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
FG002
ABCWY High Dose Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
FG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
FG004
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
FG005
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
FG006
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
FG007
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
FG008
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
FG009
ABCWY Low dose_01 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
FG010
ABCWY High dose_01 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
FG011
ABCWY Low doseS_02 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
FG012
ABCWY High doseS_02 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
FG013
ABCWY Low doseS_06 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
FG014
ABCWY High doseS_06 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
FG00012 subjects
FG0014 subjects
FG00213 subjects
FG0033 subjects
FG004239 subjects
FG005181 subjects
FG006238 subjects
FG007194 subjects
FG008197 subjects
FG00954 subjects
FG01053 subjects
FG01162 subjects
FG01262 subjects
FG01362 subjects
FG01463 subjects
COMPLETED
FG00011 subjects
FG0014 subjects
FG00211 subjects
FG0033 subjects
FG004209 subjects
FG005166 subjects
FG006218 subjects
FG007175 subjects
FG008182 subjects
FG00953 subjects
FG01050 subjects
FG01159 subjects
FG01261 subjects
FG01360 subjects
FG01456 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG00430 subjects
FG00515 subjects
FG00620 subjects
FG00719 subjects
FG00815 subjects
FG0091 subjects
FG0103 subjects
FG0113 subjects
FG0121 subjects
FG0132 subjects
FG0147 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0143 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
ADVERSE EVENT REQUIRING EXPEDITED REPORT
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
MIGRATED / MOVED FROM THE STUDY AREA
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other, Not Specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
BG001
Placebo Low Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
BG002
ABCWY High Dose Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
BG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
BG004
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
BG005
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
BG006
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
BG007
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
BG008
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
BG009
ABCWY Low dose_01 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
BG010
ABCWY High dose_01 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
BG011
ABCWY Low doseS_02 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
BG012
ABCWY High doseS_02 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
BG013
ABCWY Low doseS_06 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
BG014
ABCWY High doseS_06 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG0014
BG00213
BG0033
BG004239
BG005181
BG006238
BG007194
BG008197
BG00954
BG01053
BG01162
BG01262
BG01362
BG01463
BG0151437
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00028.6± 7.5
BG00130.8± 6.2
BG00231.7± 6.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
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
Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in)
The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Analysis was performed on the Phase I Exposed set (ES), which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 1
ID
Title
Description
OG000
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG001
Placebo Low Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
OG002
ABCWY High Dose Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
Units
Counts
Participants
OG00012
OG0014
OG00213
OG003
Title
Denominators
Categories
Erythema
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in)
The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Analysis was performed on the Phase I Exposed set (ES), which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 31
ID
Title
Description
OG000
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG001
Placebo Low Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
OG002
ABCWY High Dose Group
Primary
Number of Participants With Solicited Systemic Events in Study Phase I (Safety Lead-in)
The solicited systemic events include fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.
Analysis was performed on the Phase I Exposed set (ES), which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 1
ID
Title
Description
OG000
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG001
Placebo Low Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
OG002
ABCWY High Dose Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
Primary
Number of Participants With Solicited Systemic Events in Study Phase I (Safety Lead-in)
The solicited systemic events include fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.
Analysis was performed on the Phase I Exposed set (ES), which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 31
ID
Title
Description
OG000
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG001
Placebo Low Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
OG002
ABCWY High Dose Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
Primary
Number of Participants With Any Unsolicited Adverse Events (AEs), Including All Serious Adverse Events (SAEs), AEs Leading to Withdrawal and AEs of Special Interest (AESIs) in Study Phase I (Safety Lead-in)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase I Exposed set (ES), which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 30 days (including the day of vaccination) following vaccination at Day 1
ID
Title
Description
OG000
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
Primary
Number of Participants With Any Unsolicited AEs, Including All SAEs, AEs Leading to Withdrawal and AESIs in Study Phase I (Safety Lead-in)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase I Exposed set (ES), which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 30 days (including the day of vaccination) following vaccination at Day 31
ID
Title
Description
OG000
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
Primary
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase I (Safety Lead-in)
A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase I Exposed set (ES), which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
Throughout the Phase 1 study period (Day 1 through Day 211)
ID
Title
Description
OG000
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG001
Placebo Low Dose Group
Primary
Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values, in Study Phase I (Safety Lead-in)
The safety laboratory data included haematological parameters (basophils, eosinophils, Erythrocytes, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine) Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Analysis was performed on the Phase I Exposed set (ES), which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
At Day 8 (7 days after the first vaccination)
ID
Title
Description
OG000
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG001
Placebo Low Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
Primary
Number of Participants With Clinically Significant Haematological and Biochemical Laboratory Values, in Study Phase I (Safety Lead-in)
Clinical laboratory testing included hematological and biochemical laboratory values. Any abnormal laboratory test result (e.g., in hematology or clinical chemistry) that was deemed clinically significant by the investigator's medical and scientific judgment, and not related to an underlying disease, was reported as an unsolicited adverse event (AE) unless it was considered by the investigator to be more severe than expected for the participant's condition. The safety laboratory data included hematological parameters (basophils, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, monocytes, platelets, and neutrophils) and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], and creatinine).
Analysis was performed on the Phase I Exposed set (ES), which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
At Day 8 (7 days after the first vaccination)
ID
Title
Description
OG000
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG001
Placebo Low Dose Group
Primary
Percentage of Blood Samples With Bactericidal Serum Activity Using Enc-hSBA Against a Panel of 110 Randomly Selected Endemic US N. Meningitidis Serogroup B Invasive Disease Strains at Study Phase II (Formulation and Schedule-finding)
The effectiveness of the MenABCWY-2Gen (low & high dose) vaccine when administered at 0,2- or 0,6-months schedule compared to MenB vaccine administered at 0,6-months schedule, against a panel of 110 randomly selected endemic N. meningitidis serogroup B strains is measured in terms of percentage of samples with bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.
Analysis was performed on the Phase II Formulation and Schedule-finding (FSF) Full Analysis Set (FAS), which included all participants who received at least one dose of the study treatment and have post-vaccination immunogenicity data for the specified analysis at specified timepoints. The allocation in a group is done in function of the randomised treatment.
Number of Participants analyzed = Total number of participants included in FAS.
Posted
Number
Percentage of blood Samples
At Day 211 (1 month after the last vaccination)
Samples
Samples
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Primary
Number of Participants With a 4-fold Rise in hSBA Titers Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune response to the MenABCWY-2Gen (low and high dose) vaccine when administered at 0,2- or 0,6-months schedule compared to MenACWY vaccine (single dose), relative to day 1 in the ABCWY and control groups (0, 6 month schedule) and day 31 in ABCWY (0, 2 month schedule) is measured in terms of number of participants achieving a 4-fold rise in hSBA titers against serogroups A, C, W and Y. The 4-fold rise is defined as: -a post-vaccination hSBA titer ≥ 16 for participants with a pre-vaccination hSBA titer < 4, -a post-vaccination hSBA titer ≥ 4 times the lower limit of quantitation (LLOQ) for participants with a pre-vaccination hSBA titer ≥LOD but \
Analysis was performed on the Phase II FSF, Per Protocol Set (PPS), which included all participants who received at least one dose of the study treatment to which they are randomised and have post-vaccination data (Full Analysis Set) for the specified analysis at specified timepoints minus participants with protocol deviations that lead to exclusion from the Per Protocol Set.
Posted
Count of Participants
Participants
At Day 211 for ABCWY groups (1 month after the last MenABCWY-2Gen vaccination) and at Day 31 for Control group (1 month after the last MenACWY vaccination)
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Primary
Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Phase II FSF, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 1
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
ABCWY High dose_06 Group
Primary
Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Phase II FSF, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 121
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
ABCWY High dose_06 Group
Primary
Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Phase II FSF, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 181
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
ABCWY High dose_06 Group
Primary
Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Analysis was performed on the Phase II FSF, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 1
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
ABCWY High dose_06 Group
Primary
Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Analysis was performed on the Phase II FSF, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 121
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
Primary
Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Analysis was performed on the Phase II FSF, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 181
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
Primary
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase II FSF, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 30 days (including the day of vaccination) following vaccination at Day 1
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Primary
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase II FSF, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 30 days (including the day of vaccination) following vaccination at Day 121
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Primary
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase II FSF, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 30 days (including the day of vaccination) following vaccination at Day 181
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Primary
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Formulation and Schedule-Finding)
A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase II FSF, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
Throughout the Phase II FSF study period (Day 1 through Day 541)
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
Primary
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 1
ID
Title
Description
OG000
ABCWY Low dose_01 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
OG001
ABCWY High dose_01 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
OG002
ABCWY Low doseS_02 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
Primary
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 31
ID
Title
Description
OG000
ABCWY Low dose_01 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
OG001
ABCWY High dose_01 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
Units
Counts
Primary
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 61
ID
Title
Description
OG000
ABCWY Low doseS_02 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
OG001
ABCWY High doseS_02 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
Units
Counts
Primary
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 181
ID
Title
Description
OG000
ABCWY Low doseS_06 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
OG001
ABCWY High doseS_06 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
Units
Counts
Primary
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 1
ID
Title
Description
OG000
ABCWY Low dose_01 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
OG001
ABCWY High dose_01 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
OG002
ABCWY Low doseS_02 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
Primary
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 31
ID
Title
Description
OG000
ABCWY Low dose_01 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
OG001
ABCWY High dose_01 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
Units
Counts
Primary
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 61
ID
Title
Description
OG000
ABCWY Low doseS_02 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
OG001
ABCWY High doseS_02 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
Units
Counts
Primary
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 7 days (including the day of vaccination) following vaccination at Day 181
ID
Title
Description
OG000
ABCWY Low doseS_06 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
OG001
ABCWY High doseS_06 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
Units
Counts
Primary
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 30 days (including the day of vaccination) following vaccination at Day 1
ID
Title
Description
OG000
ABCWY Low dose_01 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
Primary
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 30 days (including the day of vaccination) following vaccination at Day 31
ID
Title
Description
OG000
ABCWY Low dose_01 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
Primary
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 30 days (including the day of vaccination) following vaccination at Day 61
ID
Title
Description
OG000
ABCWY Low doseS_02 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
Primary
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes any 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. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
During the 30 days (including the day of vaccination) following vaccination at Day 181
ID
Title
Description
OG000
ABCWY Low doseS_06 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
Primary
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)
A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
Throughout the study period (Day 1 through Day 211)
ID
Title
Description
OG000
ABCWY Low dose_01 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
OG001
ABCWY High dose_01 Group
Primary
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)
A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
Throughout the study period (Day 1 through Day 241)
ID
Title
Description
OG000
ABCWY Low doseS_02 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
OG001
ABCWY High doseS_02 Group
Primary
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)
A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Analysis was performed on the Phase II Sourcing, Exposed set, which included all participants who received at least one dose of the study treatment and have post-vaccination data for the specified analysis at specified timepoints. Allocation per group using the enrolled set is based on the treatment administered.
Posted
Count of Participants
Participants
Throughout the study period (Day 1 through Day 361)
ID
Title
Description
OG000
ABCWY Low doseS_06 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
OG001
ABCWY High doseS_06 Group
Secondary
Percentage of Participants Classified by Percentages of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Participant in Study Phase II (Formulation and Schedule-finding)
The percentages of strains killed measured by enc-hSBA against a randomly selected panel of strains and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method is calculated in all groups at 1 month after the last vaccination of MenABCWY-2Gen (low and high dose) vaccine administered at 0,2 and 0,6-months schedule and of the MenB vaccine administered at 0,6-months schedule.
Analysis was performed on the Phase II FSF Full Analysis Set, which included all participants at least 1 dose of the study intervention and have post-vaccination immunogenicity data for the specified analysis at specified timepoints. The allocation in a group is done in function of the randomised intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 211 (1 month after the last vaccination)
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
Secondary
Number of Participants With hSBA Titers ≥ LLOQ for Each and All Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
The immune response to MenABCWY-2Gen (low and high dose) administered at 0,2 and 0,6-months schedule and MenB vaccine administered at 0,6-months schedule is evaluated by measuring bactericidal activity using a qualified AO hSBA against a standard panel of serogroup B indicator strains.
Analysis was performed on the Phase II FSF Full Analysis Set, which included all participants at least 1 dose of the study intervention and have post-vaccination immunogenicity data for the specified analysis at specified timepoints. The allocation in a group is done in function of the randomised intervention.
Posted
Count of Participants
Participants
At Day 1 in ABCWY (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2-months) and Day 211 in all study groups
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Secondary
Number of Participants With 4-fold Rise in hSBA Titers Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
The immune response to MenABCWY-2Gen (low and high dose) vaccine when administered at 0,2- or 0,6-months schedule and to MenB vaccine administered at 0,6-months schedule, relative to day 1 in ABCWY (0,6 month schedule) and control groups and day 31 in ABCWY (0,2 month schedule) is measured in terms of number of participants achieving a 4-fold rise in hSBA titers against serogroup B indicator strains. The 4-fold rise is defined as: -a post-vaccination hSBA titer ≥ 16 for participants with a pre-vaccination hSBA titre < 4, -a post-vaccination hSBA titer ≥ 4 times the LLOQ for participants with a pre-vaccination hSBA titer ≥LOD but \
Analysis was performed on the Phase II FSF Full Analysis Set, which included all participants at least 1 dose of the study intervention and have post-vaccination immunogenicity data for the specified analysis at specified timepoints. The allocation in a group is done in function of the randomised intervention.
Posted
Count of Participants
Participants
At Day 211 (1 month after the last vaccination)
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
Secondary
hSBA Geometric Mean Titers (GMTs) Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
For each B strains, the GMTs are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
Analysis was performed on the Phase II FSF Full Analysis Set, which included all participants at least 1 dose of the study intervention and have post-vaccination immunogenicity data for the specified analysis at specified timepoints. The allocation in a group is done in function of the randomised intervention.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 1 in ABCWY groups (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2-months) and Day 211 in all study groups
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG002
Secondary
hSBA Geometric Mean Ratios (GMRs) Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
For each B strains, the GMRs (post-vaccination/ Baseline) are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
Analysis was performed on the Phase II FSF Full Analysis Set, which included all participants at least 1 dose of the study intervention and have post-vaccination immunogenicity data for the specified analysis at specified timepoints. The allocation in a group is done in function of the randomised intervention.
Posted
Geometric Mean
95% Confidence Interval
Ratio
At Day 211 in all study groups versus Day 1 in ABCWY (0,6-months) and Control groups and Day 31 in ABCWY groups (0,2-months)
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
Secondary
Number of Participants With hSBA Titers ≥ LLOQ for Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The number of participants with hSBA titers ≥ LLOQ and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method are calculated. Baseline (pre-vaccination) was evaluated at Day 1 for 0,6 schedules and Control, at Month 1 for 0,2 schedules. Post vaccination was evaluated at Month 7 for all MenABCWY groups, at Month 1 for Control group.
Analysis was performed on the Phase II FSF Full Analysis Set, which included all participants at least 1 dose of the study intervention and have post-vaccination immunogenicity data for the specified analysis at specified timepoints. The allocation in a group is done in function of the randomised intervention.
Posted
Count of Participants
Participants
Day 1 in ABCWY (0,6 Months) & Control; Day 31 pre-vaccination in ABCWY (0,2 Months); Day 31 post-first MenABCWY-2Gen in ABCWY (0,6 Months); Day 211 post-last MenABCWY-2Gen in all ABCWY; Day 31 post-MenACWY in Control
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Secondary
Number of Participants With a 4-fold Rise in hSBA Titers Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune response to the MenABCWY-2Gen (low and high dose) vaccine when administered at 0,6-months schedule, relative to day 1 was measured in terms of percentage of participants achieving a 4-fold rise in hSBA titers against serogroups A, C, W and Y. Serum bactericidal activity against MenACWY were determined by using a validated AO hSBA. The 4-fold rise is defined as: -a post-vaccination hSBA titre ≥ 16 for participants with a pre-vaccination hSBA titre < 4, -a post-vaccination hSBA titre ≥ 4 times the LLOQ for participants with a pre-vaccination hSBA titre ≥ LOD but < LLOQ, and. -a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ.
Analysis was performed on the Phase II FSF Full Analysis Set, which included all participants at least 1 dose of the study intervention and have post-vaccination immunogenicity data for the specified analysis at specified timepoints. The allocation in a group is done in function of the randomised intervention.
Posted
Count of Participants
Participants
At Day 31 (1 month after the first MenABCWY-2Gen vaccination) in ABCWY (0,6-months) groups
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
Secondary
hSBA GMTs Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune response to the MenABCWY-2Gen (low and high dose) vaccine (0,2- and 0,6-months schedule) and MenACWY vaccine (single dose) was evaluated by hSBA titers which are logarithmically transformed (base10) to fulfil the normal distribution assumption. For each serogroup A, C, W and Y, the GMTs are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
Analysis was performed on the Phase II FSF Full Analysis Set, which included all participants at least 1 dose of the study intervention and have post-vaccination immunogenicity data for the specified analysis at specified timepoints. The allocation in a group is done in function of the randomised intervention.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 1 in ABCWY (0,6 Months) & Control; Day 31 pre-vaccination in ABCWY (0,2 Months); Day 31 post-first MenABCWY-2Gen in ABCWY (0,6 Months); Day 211 post-last MenABCWY-2Gen in all ABCWY; Day 31 post-MenACWY in Control
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Secondary
hSBA GMRs Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
For each serogroup A, C, W and Y, the GMRs (post-vaccination/ Day 1 (Month 0)) are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
Analysis was performed on the Phase II FSF Full Analysis Set, which included all participants at least 1 dose of the study intervention and have post-vaccination immunogenicity data for the specified analysis at specified timepoints. The allocation in a group is done in function of the randomised intervention.
Posted
Geometric Mean
95% Confidence Interval
Ratio
At Day 31 [for ABCWY (0,6-months) and Control group compared to Day 1 (Baseline)], at Day 211 [for ABCWY (0,6-months) groups compared to Day 1 (baseline) and for ABCWY (0,2-months) groups compared to Day 31]
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Secondary
Immunoglobulin G (IgG) Antibodies Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune responses to MenABCWY-2Gen (low and high dose) and MenACWY vaccines are evaluated by measuring the total IgG in terms of electrochemiluminescence-based (ECL) multiplex assay Geometric Mean Concentrations (GMCs).
Analysis was performed on the Phase II FSF Full Analysis Set, which included all participants at least 1 dose of the study intervention and have post-vaccination immunogenicity data for the specified analysis at specified timepoints. The allocation in a group is done in function of the randomised intervention.
Posted
Geometric Mean
95% Confidence Interval
Microgram per milliliter(µg/mL)
Day 1 in ABCWY (0,6 Months) & Control; Day 31 pre-vaccination in ABCWY (0,2 Months); Day 31 post-first MenABCWY-2Gen in ABCWY (0,6 Months); Day 211 post-last MenABCWY-2Gen in all ABCWY; Day 31 post-MenACWY in Control
ID
Title
Description
OG000
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG001
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
Time Frame
Solicited AEs: during the 7-day follow-up period after any vaccination and Unsolicited AEs: during the 30-day follow-up period after any vaccination in all the 3 phases. SAEs, AEs leading to withdrawal & AESIs were collected throughout the study period: from Day 1 up to study end [Day 211] in Phase I (Safety Lead-in); from Day 1 up to study end [Day 541] in Phase II (Formulation and Schedule-Finding); from Day 1 up to study end [Day 361] in Phase II (Sourcing).
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
ABCWY Low Dose Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
0
12
0
12
12
12
EG001
Placebo Low Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
0
4
0
4
3
4
EG002
ABCWY High Dose Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
0
13
0
13
13
13
EG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
0
3
0
3
2
3
EG004
ABCWY Low dose_06 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
0
239
9
239
229
239
EG005
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
0
181
7
181
170
181
EG006
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
0
238
4
238
234
238
EG007
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
0
194
4
194
182
194
EG008
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
0
197
2
197
192
197
EG009
ABCWY Low dose_01 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
0
54
0
54
50
54
EG010
ABCWY High dose_01 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
0
53
0
53
53
53
EG011
ABCWY Low doseS_02 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
0
62
2
62
61
62
EG012
ABCWY High doseS_02 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
0
62
1
62
58
62
EG013
ABCWY Low doseS_06 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
0
62
0
62
60
62
EG014
ABCWY High doseS_06 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
0
63
4
63
62
63
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Blood loss anaemia
Blood and lymphatic system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected239 at risk
EG0050 events0 affected181 at risk
EG0060 events0 affected238 at risk
EG0070 events0 affected194 at risk
EG0080 events0 affected197 at risk
EG0090 events0 affected54 at risk
EG0100 events0 affected53 at risk
EG0110 events0 affected62 at risk
EG0120 events0 affected62 at risk
EG0130 events0 affected62 at risk
EG0140 events0 affected63 at risk
Mesenteric lymphadenitis
Blood and lymphatic system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Arrhythmia
Cardiac disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Atrial fibrillation
Cardiac disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Myocarditis
Cardiac disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Benign familial haematuria
Congenital, familial and genetic disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Cyst
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Appendicitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Cellulitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Enterobiasis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pharyngeal abscess
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pilonidal disease
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pneumonia
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pneumonia bacterial
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pyelonephritis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tonsillitis bacterial
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vestibular neuronitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Viral infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Bell's palsy
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Epilepsy
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Migraine
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Premature labour
Pregnancy, puerperium and perinatal conditions
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Depression
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Paranoid personality disorder
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Psychotic disorder
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Ureteric stenosis
Renal and urinary disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected239 at risk
EG0050 events0 affected181 at risk
EG0061 events1 affected238 at risk
EG0070 events0 affected194 at risk
EG0080 events0 affected197 at risk
EG0090 events0 affected54 at risk
EG0100 events0 affected53 at risk
EG0110 events0 affected62 at risk
EG0120 events0 affected62 at risk
EG0130 events0 affected62 at risk
EG0140 events0 affected63 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Sinus tachycardia
Cardiac disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tachycardia
Cardiac disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Ear pain
Ear and labyrinth disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Inner ear inflammation
Ear and labyrinth disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Motion sickness
Ear and labyrinth disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tinnitus
Ear and labyrinth disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tympanic membrane perforation
Ear and labyrinth disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vertigo
Ear and labyrinth disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Hyperprolactinaemia
Endocrine disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Hyperthyroidism
Endocrine disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Hypothyroidism
Endocrine disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Polycystic ovarian syndrome
Endocrine disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Blepharitis
Eye disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Conjunctival hyperaemia
Eye disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Conjunctivitis allergic
Eye disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Eye irritation
Eye disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Eye pain
Eye disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Panophthalmitis
Eye disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Photophobia
Eye disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected13 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Anal fissure
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Coeliac disease
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Constipation
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Dental caries
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Dyspepsia
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Enteritis
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Food poisoning
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Gastritis
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Gingival swelling
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Haematemesis
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected13 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Lip swelling
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0012 events1 affected4 at risk
EG0025 events4 affected13 at risk
EG003
Odynophagia
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Stomatitis
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tooth impacted
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Toothache
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vomiting
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Administration site erythema
General disorders
v27.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Administration site hypoaesthesia
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Administration site induration
General disorders
v27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Administration site pain
General disorders
v27.0
Systematic Assessment
EG00019 events11 affected12 at risk
EG0012 events2 affected4 at risk
EG00221 events13 affected13 at risk
EG003
Administration site swelling
General disorders
v27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Administration site warmth
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Asthenia
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Axillary pain
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Chest pain
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected13 at risk
EG003
Chills
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Fatigue
General disorders
v27.0
Systematic Assessment
EG0007 events6 affected12 at risk
EG0013 events3 affected4 at risk
EG00218 events12 affected13 at risk
EG003
Hangover
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Inflammation
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Influenza like illness
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site bruising
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site discomfort
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site erythema
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected13 at risk
EG003
Injection site haemorrhage
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site hypoaesthesia
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site induration
General disorders
v27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site lymphadenopathy
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site mass
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site nodule
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site oedema
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site pain
General disorders
v27.0
Systematic Assessment
EG0005 events2 affected12 at risk
EG0010 events0 affected4 at risk
EG0025 events5 affected13 at risk
EG003
Injection site paraesthesia
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site pruritus
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site rash
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site reaction
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site swelling
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Injection site warmth
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Malaise
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Medical device site pruritus
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pain
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected13 at risk
EG003
Peripheral swelling
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pyrexia
General disorders
v27.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected13 at risk
EG003
Swelling
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Swelling face
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vaccination site erythema
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vaccination site pain
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vaccination site pruritus
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vaccination site swelling
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vaccination site warmth
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vessel puncture site pain
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Food allergy
Immune system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Hypersensitivity
Immune system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Mite allergy
Immune system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Mycotic allergy
Immune system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Seasonal allergy
Immune system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Abscess neck
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Acarodermatitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Acute sinusitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Adenovirus infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Alveolar osteitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Body tinea
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Bronchitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
COVID-19
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Cellulitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Chlamydial infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Conjunctivitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Coronavirus infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Cystitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Dengue fever
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Ear infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Enterovirus infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Folliculitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Gastroenteritis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Gastroenteritis viral
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Gastrointestinal infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Helicobacter infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Herpes simplex
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Hordeolum
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Impetigo
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Infectious mononucleosis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Influenza
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Laryngitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Lyme disease
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Metapneumovirus infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Nasopharyngitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Norovirus infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Onychomycosis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Oral fungal infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Oral herpes
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Otitis externa
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Otitis media
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Otitis media acute
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Ovarian bacterial infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Paronychia
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pharyngitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pharyngitis bacterial
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pneumonia
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Post-acute COVID-19 syndrome
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pustule
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Respiratory tract infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Rhinitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Sinusitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Sinusitis bacterial
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Skin infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Suspected COVID-19
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tinea versicolour
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tonsillitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tonsillitis bacterial
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tonsillitis streptococcal
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tooth abscess
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tracheitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Upper respiratory tract infection
Infections and infestations
v27.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected13 at risk
EG003
Urinary tract infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Viral infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Viral pharyngitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected13 at risk
EG003
Viral rash
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vulval abscess
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vulvovaginitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Accident
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Accidental exposure to product
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Cartilage injury
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Concussion
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Contusion
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Craniofacial fracture
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Eyelid injury
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Fall
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Heat exhaustion
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Immunisation reaction
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected13 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Procedural complication
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Repetitive strain injury
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Skin injury
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected13 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Traumatic pain
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Blood iron decreased
Investigations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Body temperature increased
Investigations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Human metapneumovirus test positive
Investigations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Streptococcus test positive
Investigations
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Hypovitaminosis
Metabolism and nutrition disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Insulin resistance
Metabolism and nutrition disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0013 events2 affected4 at risk
EG0024 events4 affected13 at risk
EG003
Axillary mass
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected13 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Inguinal mass
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Jaw disorder
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Muscle disorder
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected13 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0005 events4 affected12 at risk
EG0011 events1 affected4 at risk
EG0027 events6 affected13 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Disturbance in attention
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Dizziness
Nervous system disorders
v27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Headache
Nervous system disorders
v27.0
Systematic Assessment
EG00011 events7 affected12 at risk
EG0012 events2 affected4 at risk
EG0029 events5 affected13 at risk
EG003
Hyperaesthesia
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Hypoaesthesia
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Lethargy
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Migraine
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Migraine with aura
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Paraesthesia
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Presyncope
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Sciatica
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Somnolence
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Syncope
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tension headache
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Anger
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Anxiety
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Anxiety disorder
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Depression
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Eating disorder
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Initial insomnia
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Insomnia
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Mixed anxiety and depressive disorder
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Neurosis
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Obsessive-compulsive disorder
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Sleep disorder
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Social anxiety disorder
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Stress
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Suicidal ideation
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Cystitis noninfective
Renal and urinary disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Haematuria
Renal and urinary disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Urethral haemorrhage
Renal and urinary disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Urethral pain
Renal and urinary disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Urge incontinence
Renal and urinary disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Cervical polyp
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Endometriosis
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Allergic sinusitis
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected13 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Nasal pruritus
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Nasal septum perforation
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pharyngeal swelling
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Tonsillolith
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Alopecia areata
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected13 at risk
EG003
Dyshidrotic eczema
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Parapsoriasis
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Sea bather's eruption
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Solar dermatitis
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Transient acantholytic dermatosis
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Urticaria chronic
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Urticaria papular
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Haematoma
Vascular disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 at risk
EG003
Hot flush
Vascular disorders
v27.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected13 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.
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
Units
Counts
Participants
OG00012
OG0014
OG00211
OG0033
Title
Denominators
Categories
Erythema
Title
Measurements
OG0002
OG0010
OG0020
OG0030
Induration
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pain
Title
Measurements
OG0008
OG0011
OG0028
OG003
Swelling
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
Units
Counts
Participants
OG00012
OG0014
OG00213
OG0033
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0001
OG0011
OG0022
OG0031
Fatigue
Title
Measurements
OG0004
OG0011
OG00211
OG003
Headache
Title
Measurements
OG0004
OG0010
OG0024
OG003
Myalgia
Title
Measurements
OG0004
OG0010
OG0023
OG003
Nausea
Title
Measurements
OG0000
OG0010
OG0023
OG003
Fever (C)
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
Units
Counts
Participants
OG00012
OG0014
OG00211
OG0033
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0001
OG0012
OG0022
OG0030
Fatigue
Title
Measurements
OG0001
OG0012
OG0027
OG003
Headache
Title
Measurements
OG0004
OG0012
OG0023
OG003
Myalgia
Title
Measurements
OG0001
OG0011
OG0022
OG003
Nausea
Title
Measurements
OG0001
OG0011
OG0022
OG003
Fever (C)
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG001
Placebo Low Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
OG002
ABCWY High Dose Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
Units
Counts
Participants
OG00012
OG0014
OG00213
OG0033
Title
Denominators
Categories
Title
Measurements
OG0004
OG0011
OG0028
OG0031
OG001
Placebo Low Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
OG002
ABCWY High Dose Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
Units
Counts
Participants
OG00012
OG0014
OG00211
OG0033
Title
Denominators
Categories
Title
Measurements
OG0006
OG0011
OG0027
OG0030
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
OG002
ABCWY High Dose Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
Units
Counts
Participants
OG00012
OG0014
OG00213
OG0033
Title
Denominators
Categories
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
AEs leading to withdrawal
Title
Measurements
OG0000
OG0010
OG0020
OG003
AESIs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
ABCWY High Dose Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
Units
Counts
Participants
OG00012
OG0014
OG00213
OG0033
Title
Denominators
Categories
Basophils
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG0030
Within (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG0030
Above (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG0030
Below (baseline) - within (Day 8)
OG0000
OG0010
OG0020
OG0030
Within (baseline) - within (Day 8)
OG00012
OG0014
OG00213
OG0033
Above (baseline) - within (Day 8)
OG0000
OG0010
OG0020
OG0030
Below (baseline) - above (Day 8)
OG0000
OG0010
OG0020
OG0030
WIthin (baseline) - above (Day 8)
OG0000
OG0010
OG0020
OG0030
Above (baseline) - above (Day 8)
OG0000
OG0010
OG0020
OG0030
Eosinophils
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG003
Erythrocytes
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG003
Hemoglobin
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG003
Leukocytes
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG003
Lymphocytes
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG003
Monocytes
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG003
Neutrophils
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG003
Platelets
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG003
Alanine Aminotransferase (ALT)
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG003
Aspartate Aminotransferase (AST)
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG003
Creatinine
Title
Measurements
Below (baseline) - below (Day 8)
OG0000
OG0010
OG0020
OG003
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
OG002
ABCWY High Dose Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
OG003
Placebo High Dose Group
Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
Units
Counts
Participants
OG00012
OG0014
OG00213
OG0033
Title
Denominators
Categories
Basophils
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Eosinophils
Title
Measurements
OG0000
OG0010
OG0020
OG003
Erythrocytes
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin
Title
Measurements
OG0000
OG0010
OG0020
OG003
Leukocytes
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes
Title
Measurements
OG0000
OG0010
OG0020
OG003
Monocytes
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelets
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alanine Aminotransferase (ALT)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Aspartate Aminotransferase (AST)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000230
OG001177
OG002235
OG003189
OG004194
Samples
OG0006714
OG0015383
OG0027063
OG0035540
OG004
Title
Denominators
Categories
Title
Measurements
OG00091.0
OG00186.2
OG00291.0
OG00388.4
OG00486.4
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
OG004
To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,6-months schedule, compared to the MenB vaccine administered at 0,6-months schedule.
Difference in percentage
4.67
2-Sided
97.5
3.38
5.97
The 97.5% CIs for the difference in percentages between ABCWY low dose_06 group and the control group is constructed using the method of Miettinen and Nurminen.
Superiority
Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose_06 group compared to the Control group at 1 month after the last vaccination.
OG001
OG004
To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.
Difference in percentage
-0.17
2-Sided
97.5
-1.65
1.30
The 97.5% CIs for the difference in percentages between ABCWY low dose_02 group and the control group is constructed using the method of Miettinen and Nurminen.
Superiority
Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose_02 group compared to the Control group at 1 month after the last vaccination.
OG002
OG004
To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,6- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.
Difference in percentage
4.60
2-Sided
97.5
3.33
5.89
The 97.5% CIs for the difference in percentages between ABCWY high dose_06 group and the control group is constructed using the method of Miettinen and Nurminen.
Superiority
Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose_06 group compared to the Control group at 1 month after the last vaccination.
OG003
OG004
To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.
Difference in percentage
2.01
2-Sided
97.5
0.60
3.42
The 97.5% CIs for the difference in percentages between ABCWY high dose_02 group and the control group is constructed using the method of Miettinen and Nurminen.
Superiority
Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose_02 group compared to the Control group at 1 month after the last vaccination.
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000135
OG001116
OG002147
OG003118
OG004159
Title
Denominators
Categories
Men A
ParticipantsOG000132
ParticipantsOG001109
ParticipantsOG002140
ParticipantsOG003112
ParticipantsOG004156
Title
Measurements
OG000125
OG001105
OG002136
OG003
Men C
ParticipantsOG000135
ParticipantsOG001113
ParticipantsOG002146
ParticipantsOG003118
Men W
ParticipantsOG000134
ParticipantsOG001114
ParticipantsOG002143
ParticipantsOG003116
Men Y
ParticipantsOG000131
ParticipantsOG001116
ParticipantsOG002147
ParticipantsOG003115
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
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).
Difference in percentage
3.03
2-Sided
97.5
-4.21
10.17
The 97.5% CIs for the difference in percentages between ABCWY low dose_06 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose_06 group compared to the MenACWY vaccination in the Control group.
OG001
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).
Difference in percentage
4.66
2-Sided
97.5
-2.71
11.64
The 97.5% CIs for the difference in percentages between ABCWY low dose_02 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose_02 group compared to the MenACWY vaccination in the Control group.
OG002
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).
Difference in percentage
5.48
2-Sided
97.5
-0.71
12.25
The 97.5% CIs for the difference in percentages between ABCWY high dose_06 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose_06 group compared to the MenACWY vaccination in the Control group.
OG003
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).
Difference in percentage
3.87
2-Sided
97.5
-3.70
10.97
The 97.5% CIs for the difference in percentages between ABCWY high dose_02 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose_02 group compared to the MenACWY vaccination in the Control group.
OG000
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).
Difference in percentage
35.03
2-Sided
97.5
25.22
44.75
The 97.5% CIs for the difference in percentages between ABCWY low dose_06 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose_06 group compared to the MenACWY vaccination in the Control group.
OG001
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).
Difference in percentage
34.16
2-Sided
97.5
23.76
44.10
The 97.5% CIs for the difference in percentages between ABCWY low dose_02 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose_02 group compared to the MenACWY vaccination in the Control group.
OG002
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).
Difference in percentage
29.88
2-Sided
97.5
19.26
40.19
The 97.5% CIs for the difference in percentages between ABCWY high dose_06 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose_06 group compared to the MenACWY vaccination in the Control group.
OG003
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).
Difference in percentage
33.54
2-Sided
97.5
23.09
43.54
The 97.5% CIs for the difference in percentages between ABCWY high dose_02 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose_02 group compared to the MenACWY vaccination in the Control group.
OG000
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).
Difference in percentage
30.88
2-Sided
97.5
21.61
40.32
The 97.5% CIs for the difference in percentages between ABCWY low dose_06 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose_06 group compared to the MenACWY vaccination in the Control group.
OG001
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).
Difference in percentage
29.35
2-Sided
97.5
19.31
39.08
The 97.5% CIs for the difference in percentages between ABCWY low dose_02 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the MenABCWY-2Gen MenACWY vaccination in the ABCWY low dose_02 group compared to the MenACWY vaccination in the Control group.
OG002
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).
Difference in percentage
29.02
2-Sided
97.5
19.42
38.67
The 97.5% CIs for the difference in percentages between ABCWY high dose_06 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose_06 group compared to the MenACWY vaccination in the Control group.
OG003
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).
Difference in percentage
25.13
2-Sided
97.5
14.20
35.45
The 97.5% CIs for the difference in percentages between ABCWY high dose_02 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose_02 group compared to the MenACWY vaccination in the Control group.
OG000
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).
Difference in percentage
33.38
2-Sided
97.5
23.08
43.26
The 97.5% CIs for the difference in percentages between ABCWY low dose_06 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose_06 group compared to the MenACWY vaccination in the Control group.
OG001
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).
Difference in percentage
28.18
2-Sided
97.5
16.61
38.86
The 97.5% CIs for the difference in percentages between ABCWY low dose_02 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose_02 group compared to the MenACWY vaccination in the Control group.
OG002
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).
Difference in percentage
29.37
2-Sided
97.5
18.67
39.63
The 97.5% CIs for the difference in percentages between ABCWY high dose_06 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose_06 group compared to the MenACWY vaccination in the Control group.
OG003
OG004
To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).
Difference in percentage
27.21
2-Sided
97.5
15.46
38.02
The 97.5% CIs for the difference in percentages between ABCWY high dose_02 group and the control group is constructed using the method of Miettinen and Nurminen.
Non-Inferiority
NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose_02 group compared to the MenACWY vaccination in the Control group.
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control (MenACWY) Group
Participants randomized to Control Group received a single dose of Menveo (MenACWY) on Day 1 during study Phase II (Formulation and Schedule-finding).
OG005
Control (MenB_06) Group
Participants randomized to Control Group received 2 doses of Bexsero (MenB) vaccine on Day 1 and Day 181 following in a 0, 6- month schedule during study Phase II (Formulation and Schedule-finding).
Units
Counts
Participants
OG000239
OG001181
OG002238
OG003194
OG004178
OG005178
Title
Denominators
Categories
Erythema
Title
Measurements
OG00032
OG0010
OG00229
OG0030
OG0046
OG00513
Induration
Title
Measurements
OG00022
OG0011
OG00230
OG003
Pain
Title
Measurements
OG000217
OG00139
OG002220
OG003
Swelling
Title
Measurements
OG00034
OG0010
OG00232
OG003
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control (MenACWY) Group
Participants randomized to Control Group received a single dose of Menveo (MenACWY) on Day 1 during study Phase II (Formulation and Schedule-finding).
OG005
Control (MenB_06) Group
Participants randomized to Control Group received 2 doses of Bexsero (MenB) vaccine on Day 1 and Day 181 following in a 0, 6- month schedule during study Phase II (Formulation and Schedule-finding).
Units
Counts
Participants
OG000220
OG001170
OG002224
OG003182
OG0040
OG0050
Title
Denominators
Categories
Erythema (mm)
Title
Measurements
OG0000
OG00117
OG0020
OG00314
Induration (mm)
Title
Measurements
OG0001
OG00115
OG0020
OG003
Pain
Title
Measurements
OG00028
OG001143
OG00226
OG003
Swelling (mm)
Title
Measurements
OG0001
OG00121
OG0020
OG003
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control (MenACWY) Group
Participants randomized to Control Group received a single dose of Menveo (MenACWY) on Day 1 during study Phase II (Formulation and Schedule-finding).
OG005
Control (MenB_06) Group
Participants randomized to Control Group received 2 doses of Bexsero (MenB) vaccine on Day 1 and Day 181 following in a 0, 6- month schedule during study Phase II (Formulation and Schedule-finding).
Units
Counts
Participants
OG000216
OG001163
OG002220
OG003176
OG0040
OG005187
Title
Denominators
Categories
Erythema
Title
Measurements
OG00023
OG00115
OG00221
OG00317
OG00518
Induration
Title
Measurements
OG00018
OG00117
OG00220
OG003
Pain
Title
Measurements
OG000191
OG001134
OG002187
OG003
Swelling
Title
Measurements
OG00027
OG00125
OG00227
OG003
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000239
OG001181
OG002238
OG003194
OG004197
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG00017
OG0016
OG00216
OG0036
OG00411
Fatigue
Title
Measurements
OG000123
OG00160
OG002109
OG003
Headache
Title
Measurements
OG00092
OG00160
OG002102
OG003
Myalgia
Title
Measurements
OG00028
OG0016
OG00223
OG003
Nausea
Title
Measurements
OG00030
OG00116
OG00223
OG003
Fever (C)
Title
Measurements
OG0004
OG0012
OG0028
OG003
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000220
OG001170
OG002224
OG003182
OG0040
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0002
OG00113
OG0024
OG0038
Fatigue
Title
Measurements
OG00046
OG00172
OG00242
OG003
Headache
Title
Measurements
OG00046
OG00156
OG00247
OG003
Myalgia
Title
Measurements
OG0004
OG00121
OG0028
OG003
Nausea
Title
Measurements
OG00013
OG0018
OG00214
OG003
Fever (C)
Title
Measurements
OG0001
OG0015
OG0022
OG003
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000216
OG001163
OG002220
OG003176
OG004187
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG00014
OG0018
OG00222
OG00313
OG0046
Fatigue
Title
Measurements
OG00086
OG00159
OG00298
OG003
Headache
Title
Measurements
OG00075
OG00159
OG00290
OG003
Myalgia
Title
Measurements
OG00026
OG00118
OG00236
OG003
Nausea
Title
Measurements
OG00022
OG00111
OG00231
OG003
Fever (C)
Title
Measurements
OG0004
OG0016
OG0028
OG003
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000239
OG001181
OG002238
OG003194
OG004197
Title
Denominators
Categories
Title
Measurements
OG00051
OG00134
OG00252
OG00335
OG00427
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000220
OG001170
OG002224
OG003182
OG0040
Title
Denominators
Categories
Title
Measurements
OG00016
OG00119
OG00222
OG00318
OG001
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000216
OG001163
OG002220
OG003176
OG004187
Title
Denominators
Categories
Title
Measurements
OG00028
OG00124
OG00242
OG00327
OG00428
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000239
OG001181
OG002238
OG003194
OG004197
Title
Denominators
Categories
SAEs
Title
Measurements
OG0009
OG0017
OG0024
OG0034
OG0042
AEs leading to withdrawal
Title
Measurements
OG0001
OG0010
OG0021
OG003
AESIs
Title
Measurements
OG0004
OG0011
OG0022
OG003
OG003
ABCWY High doseS_02 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
OG004
ABCWY Low doseS_06 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
OG005
ABCWY High doseS_06 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
Units
Counts
Participants
OG00054
OG00153
OG00262
OG00362
OG00462
OG00563
Title
Denominators
Categories
Erythema
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Induration
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pain
Title
Measurements
OG0002
OG0014
OG0023
OG003
Swelling
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants
OG00050
OG00147
Title
Denominators
Categories
Erythema
Title
Measurements
OG0000
OG0011
Induration
Title
Measurements
OG0000
OG0010
Pain
Title
Measurements
OG0000
OG0011
Swelling
Title
Measurements
OG0000
OG0011
Participants
OG00058
OG00160
Title
Denominators
Categories
Erythema
Title
Measurements
OG0000
OG0010
Induration
Title
Measurements
OG0000
OG0010
Pain
Title
Measurements
OG0002
OG0013
Swelling
Title
Measurements
OG0000
OG0010
Participants
OG00060
OG00155
Title
Denominators
Categories
Erythema
Title
Measurements
OG0000
OG0010
Induration
Title
Measurements
OG0000
OG0010
Pain
Title
Measurements
OG0004
OG0013
Swelling
Title
Measurements
OG0000
OG0010
OG003
ABCWY High doseS_02 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
OG004
ABCWY Low doseS_06 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
OG005
ABCWY High doseS_06 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
Units
Counts
Participants
OG00054
OG00153
OG00262
OG00362
OG00462
OG00563
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
Fatigue
Title
Measurements
OG0002
OG0011
OG0022
OG003
Headache
Title
Measurements
OG0003
OG0010
OG0020
OG003
Myalgia
Title
Measurements
OG0001
OG0010
OG0021
OG003
Nausea
Title
Measurements
OG0002
OG0011
OG0020
OG003
Fever (C)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants
OG00050
OG00147
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0000
OG0010
Fatigue
Title
Measurements
OG0001
OG0010
Headache
Title
Measurements
OG0000
OG0013
Myalgia
Title
Measurements
OG0000
OG0010
Nausea
Title
Measurements
OG0000
OG0012
Fever (C)
Title
Measurements
OG0000
OG0010
Participants
OG00058
OG00160
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0000
OG0010
Fatigue
Title
Measurements
OG0000
OG0010
Headache
Title
Measurements
OG0000
OG0010
Myalgia
Title
Measurements
OG0001
OG0010
Nausea
Title
Measurements
OG0000
OG0010
Fever (C)
Title
Measurements
OG0000
OG0010
Participants
OG00060
OG00155
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0000
OG0010
Fatigue
Title
Measurements
OG0000
OG0010
Headache
Title
Measurements
OG0000
OG0010
Myalgia
Title
Measurements
OG0000
OG0010
Nausea
Title
Measurements
OG0000
OG0010
Fever (C)
Title
Measurements
OG0000
OG0010
OG001
ABCWY High dose_01 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
OG002
ABCWY Low doseS_02 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
OG003
ABCWY High doseS_02 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
OG004
ABCWY Low doseS_06 Group
Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
OG005
ABCWY High doseS_06 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
Units
Counts
Participants
OG00054
OG00153
OG00262
OG00362
OG00462
OG00563
Title
Denominators
Categories
Title
Measurements
OG00010
OG00112
OG00214
OG0038
OG00410
OG00518
OG001
ABCWY High dose_01 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
Units
Counts
Participants
OG00050
OG00147
Title
Denominators
Categories
Title
Measurements
OG00011
OG00116
OG001
ABCWY High doseS_02 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
Units
Counts
Participants
OG00058
OG00160
Title
Denominators
Categories
Title
Measurements
OG0008
OG0017
OG001
ABCWY High doseS_06 Group
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
Units
Counts
Participants
OG00060
OG00155
Title
Denominators
Categories
Title
Measurements
OG00010
OG0019
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
Units
Counts
Participants
OG00054
OG00153
Title
Denominators
Categories
SAEs
Title
Measurements
OG0000
OG0010
AEs leading to withdrawal
Title
Measurements
OG0000
OG0010
AESIs
Title
Measurements
OG0000
OG0010
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
Units
Counts
Participants
OG00062
OG00162
Title
Denominators
Categories
SAEs
Title
Measurements
OG0002
OG0011
AEs leading to withdrawal
Title
Measurements
OG0001
OG0010
AESIs
Title
Measurements
OG0000
OG0011
Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
Units
Counts
Participants
OG00062
OG00163
Title
Denominators
Categories
SAEs
Title
Measurements
OG0000
OG0014
AEs leading to withdrawal
Title
Measurements
OG0000
OG0012
AESIs
Title
Measurements
OG0000
OG0010
OG002
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000205
OG001161
OG002215
OG003169
OG004176
Title
Denominators
Categories
>= (greater than/equal to) 50% killed strains
Title
Measurements
OG00098.5(95.8 to 99.7)
OG00197.5(93.8 to 99.3)
OG00297.7(94.7 to 99.2)
OG00398.8(95.8 to 99.9)
OG00498.3(95.1 to 99.6)
>=55% killed strains
Title
Measurements
OG00098.0(95.1 to 99.5)
OG00195.7(91.2 to 98.2)
OG00297.7(94.7 to 99.2)
OG003
>=60% killed strains
Title
Measurements
OG00096.6(93.1 to 98.6)
OG00195.0(90.4 to 97.8)
OG00297.2(94.0 to 99.0)
OG003
>=65% killed strains
Title
Measurements
OG00095.6(91.8 to 98.0)
OG00192.5(87.3 to 96.1)
OG00296.3(92.8 to 98.4)
OG003
>=70% killed strains
Title
Measurements
OG00094.1(90.0 to 96.9)
OG00189.4(83.6 to 93.7)
OG00294.4(90.5 to 97.1)
OG003
>=75% killed strains
Title
Measurements
OG00091.2(86.5 to 94.7)
OG00182.0(75.2 to 87.6)
OG00290.2(85.5 to 93.9)
OG003
>=80% killed strains
Title
Measurements
OG00088.8(83.6 to 92.8)
OG00177.6(70.4 to 83.8)
OG00287.4(82.3 to 91.6)
OG003
>=85% killed strains
Title
Measurements
OG00082.9(77.1 to 87.8)
OG00164.6(56.7 to 72.0)
OG00282.8(77.1 to 87.6)
OG003
>=90% killed strains
Title
Measurements
OG00071.2(64.5 to 77.3)
OG00153.4(45.4 to 61.3)
OG00270.7(64.1 to 76.7)
OG003
>=95% killed strains
Title
Measurements
OG00043.4(36.5 to 50.5)
OG00129.2(22.3 to 36.9)
OG00244.2(37.4 to 51.1)
OG003
100% killed strains
Title
Measurements
OG00023.4(17.8 to 29.8)
OG00114.3(9.3 to 20.7)
OG00224.2(18.6 to 30.5)
OG003
OG002
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000209
OG001214
OG002173
OG003189
OG004194
Title
Denominators
Categories
fHbp, Day 1
ParticipantsOG000209
ParticipantsOG001214
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG004194
Title
Measurements
OG0009
OG00110
OG00412
fHbp, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002173
ParticipantsOG003189
fHbp, Day 211
ParticipantsOG000201
ParticipantsOG001213
ParticipantsOG002159
ParticipantsOG003168
NadA, Day 1
ParticipantsOG000201
ParticipantsOG001211
ParticipantsOG0020
ParticipantsOG0030
NadA, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002168
ParticipantsOG003185
NadA, Day 211
ParticipantsOG000197
ParticipantsOG001201
ParticipantsOG002150
ParticipantsOG003162
NHBA, Day 1
ParticipantsOG000207
ParticipantsOG001213
ParticipantsOG0020
ParticipantsOG0030
NHBA, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002172
ParticipantsOG003186
NHBA, Day 211
ParticipantsOG000199
ParticipantsOG001212
ParticipantsOG002155
ParticipantsOG003167
PorA, Day 1
ParticipantsOG000208
ParticipantsOG001213
ParticipantsOG0020
ParticipantsOG0030
PorA, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002161
ParticipantsOG003173
PorA, Day 211
ParticipantsOG000200
ParticipantsOG001214
ParticipantsOG002153
ParticipantsOG003169
fHbp V1.13, Day 1
ParticipantsOG000203
ParticipantsOG001209
ParticipantsOG0020
ParticipantsOG0030
fHbp V1.13, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002171
ParticipantsOG003184
fHbp V1.13, Day 211
ParticipantsOG000188
ParticipantsOG001194
ParticipantsOG002142
ParticipantsOG003148
fHbp V2, Day 1
ParticipantsOG000203
ParticipantsOG001209
ParticipantsOG0020
ParticipantsOG0030
fHbp V2, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002171
ParticipantsOG003184
fHbp V2, Day 211
ParticipantsOG000195
ParticipantsOG001204
ParticipantsOG002150
ParticipantsOG003161
fHbp V3, Day 1
ParticipantsOG000203
ParticipantsOG001209
ParticipantsOG0020
ParticipantsOG0030
fHbp V3, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002172
ParticipantsOG003184
fHbp V3, Day 211
ParticipantsOG000194
ParticipantsOG001204
ParticipantsOG002151
ParticipantsOG003162
Composite Response, Day 1
ParticipantsOG000194
ParticipantsOG001206
ParticipantsOG0020
ParticipantsOG0030
Composite Response, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002151
ParticipantsOG003164
Composite Response, Day 211
ParticipantsOG000180
ParticipantsOG001181
ParticipantsOG002131
ParticipantsOG003134
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG002
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000178
OG001155
OG002193
OG003168
OG004177
Title
Denominators
Categories
fHbp
ParticipantsOG000178
ParticipantsOG001155
ParticipantsOG002193
ParticipantsOG003168
ParticipantsOG004177
Title
Measurements
OG000144
OG00189
OG002155
OG003
NadA
ParticipantsOG000166
ParticipantsOG001141
ParticipantsOG002179
ParticipantsOG003159
NHBA
ParticipantsOG000174
ParticipantsOG001150
ParticipantsOG002191
ParticipantsOG003164
PorA
ParticipantsOG000175
ParticipantsOG001140
ParticipantsOG002193
ParticipantsOG003157
fHbp V1.13
ParticipantsOG000162
ParticipantsOG001137
ParticipantsOG002173
ParticipantsOG003144
fHbp V2
ParticipantsOG000168
ParticipantsOG001144
ParticipantsOG002182
ParticipantsOG003157
fHbp V3
ParticipantsOG000167
ParticipantsOG001146
ParticipantsOG002182
ParticipantsOG003158
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000209
OG001214
OG002173
OG003189
OG004194
Title
Denominators
Categories
fHbp, Day 1
ParticipantsOG000209
ParticipantsOG001214
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG004194
Title
Measurements
OG0008.7(8.1 to 9.3)
OG0018.8(8.2 to 9.4)
OG0048.9(8.3 to 9.6)
fHbp, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002173
ParticipantsOG003189
fHbp, Day 211
ParticipantsOG000201
ParticipantsOG001213
ParticipantsOG002159
ParticipantsOG003168
NadA, Day 1
ParticipantsOG000201
ParticipantsOG001211
ParticipantsOG0020
ParticipantsOG0030
NadA, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002168
ParticipantsOG003185
NadA, Day 211
ParticipantsOG000197
ParticipantsOG001201
ParticipantsOG002150
ParticipantsOG003162
NHBA, Day 1
ParticipantsOG000207
ParticipantsOG001213
ParticipantsOG0020
ParticipantsOG0030
NHBA, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002172
ParticipantsOG003186
NHBA, Day 211
ParticipantsOG000199
ParticipantsOG001212
ParticipantsOG002155
ParticipantsOG003167
PorA, Day 1
ParticipantsOG000208
ParticipantsOG001213
ParticipantsOG0020
ParticipantsOG0030
PorA, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002161
ParticipantsOG003173
PorA, Day 211
ParticipantsOG000200
ParticipantsOG001214
ParticipantsOG002153
ParticipantsOG003169
fHbp V1.13, Day 1
ParticipantsOG000203
ParticipantsOG001209
ParticipantsOG0020
ParticipantsOG0030
fHbp V1.13, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002171
ParticipantsOG003184
fHbp V1.13, Day 211
ParticipantsOG000188
ParticipantsOG001194
ParticipantsOG002142
ParticipantsOG003148
fHbp V2, Day 1
ParticipantsOG000203
ParticipantsOG001209
ParticipantsOG0020
ParticipantsOG0030
fHbp V2, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002171
ParticipantsOG003184
fHbp V2, Day 211
ParticipantsOG000195
ParticipantsOG001204
ParticipantsOG002150
ParticipantsOG003161
fHbp V3, Day 1
ParticipantsOG000203
ParticipantsOG001209
ParticipantsOG0020
ParticipantsOG0030
fHbp V3, Day 31
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002172
ParticipantsOG003184
fHbp V3, Day 211
ParticipantsOG000194
ParticipantsOG001204
ParticipantsOG002151
ParticipantsOG003162
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000178
OG001155
OG002193
OG003168
OG004177
Title
Denominators
Categories
fHbp
ParticipantsOG000178
ParticipantsOG001155
ParticipantsOG002193
ParticipantsOG003168
ParticipantsOG004177
Title
Measurements
OG00013.4(10.5 to 17.2)
OG0015.6(4.3 to 7.2)
OG00216.5(12.9 to 21.0)
OG003
NadA
ParticipantsOG000166
ParticipantsOG001141
ParticipantsOG002179
ParticipantsOG003159
NHBA
ParticipantsOG000174
ParticipantsOG001150
ParticipantsOG002191
ParticipantsOG003164
PorA
ParticipantsOG000175
ParticipantsOG001140
ParticipantsOG002193
ParticipantsOG003157
fHbp V1.13
ParticipantsOG000162
ParticipantsOG001137
ParticipantsOG002173
ParticipantsOG003144
fHbp V2
ParticipantsOG000168
ParticipantsOG001144
ParticipantsOG002182
ParticipantsOG003157
fHbp V3
ParticipantsOG000167
ParticipantsOG001146
ParticipantsOG002182
ParticipantsOG003158
OG002
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000222
OG001226
OG002175
OG003189
OG004193
Title
Denominators
Categories
Men A, Day 1
ParticipantsOG000208
ParticipantsOG001201
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG004190
Title
Measurements
OG00023
OG00112
OG00420
Men A, Day 31 (Pre vaccination)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002170
ParticipantsOG003184
Men A, Day 31 (Post vaccination)
ParticipantsOG000204
ParticipantsOG001221
ParticipantsOG0020
ParticipantsOG0030
Men A, Day 211 (Post vaccination)
ParticipantsOG000202
ParticipantsOG001212
ParticipantsOG002159
ParticipantsOG003167
Men C, Day 1
ParticipantsOG000209
ParticipantsOG001211
ParticipantsOG0020
ParticipantsOG0030
Men C, Day 31 (Pre vaccination)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002173
ParticipantsOG003189
Men C, Day 31 (Post vaccination)
ParticipantsOG000219
ParticipantsOG001217
ParticipantsOG0020
ParticipantsOG0030
Men C, Day 211 (Post vaccination)
ParticipantsOG000204
ParticipantsOG001213
ParticipantsOG002160
ParticipantsOG003171
Men W, Day 1
ParticipantsOG000207
ParticipantsOG001210
ParticipantsOG0020
ParticipantsOG0030
Men W, Day 31 (Pre vaccination)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002173
ParticipantsOG003187
Men W, Day 31 (Post vaccination)
ParticipantsOG000222
ParticipantsOG001221
ParticipantsOG0020
ParticipantsOG0030
Men W, Day 211 (Post vaccination)
ParticipantsOG000204
ParticipantsOG001213
ParticipantsOG002161
ParticipantsOG003169
Men Y, Day 1
ParticipantsOG000207
ParticipantsOG001211
ParticipantsOG0020
ParticipantsOG0030
Men Y, Day 31 (Pre vaccination)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002175
ParticipantsOG003187
Men Y, Day 31 (Post vaccination)
ParticipantsOG000222
ParticipantsOG001226
ParticipantsOG0020
ParticipantsOG0030
Men Y, Day 211 (Post vaccination)
ParticipantsOG000203
ParticipantsOG001214
ParticipantsOG002161
ParticipantsOG003169
ABCWY High dose_06 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
OG002
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000194
OG001201
OG002186
Title
Denominators
Categories
Men A
ParticipantsOG000176
ParticipantsOG001186
ParticipantsOG002180
Title
Measurements
OG000145
OG001145
OG002166
Men C
ParticipantsOG000193
ParticipantsOG001192
ParticipantsOG002178
Title
Measurements
OG000
Men W
ParticipantsOG000194
ParticipantsOG001195
ParticipantsOG002183
Title
Measurements
OG000
Men Y
ParticipantsOG000193
ParticipantsOG001201
ParticipantsOG002186
Title
Measurements
OG000
OG002
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000222
OG001226
OG002181
OG003194
OG004193
Title
Denominators
Categories
Men A, Day 1
ParticipantsOG000208
ParticipantsOG001201
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG004190
Title
Measurements
OG0009.7(8.5 to 11.2)
OG0018.7(7.5 to 10.0)
OG0049.3(8.0 to 10.7)
Men A, Day 31 (Pre vaccination)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002181
ParticipantsOG003194
Men A, Day 31 (Post vaccination)
ParticipantsOG000204
ParticipantsOG001221
ParticipantsOG0020
ParticipantsOG0030
Men A, Day 211 (Post vaccination)
ParticipantsOG000202
ParticipantsOG001212
ParticipantsOG002159
ParticipantsOG003167
Men C, Day 1
ParticipantsOG000209
ParticipantsOG001211
ParticipantsOG0020
ParticipantsOG0030
Men C, Day 31 (Pre vaccination)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002173
ParticipantsOG003189
Men C, Day 31 (Post vaccination)
ParticipantsOG000219
ParticipantsOG001217
ParticipantsOG0020
ParticipantsOG0030
Men C, Day 211 (Post vaccination)
ParticipantsOG000204
ParticipantsOG001213
ParticipantsOG002160
ParticipantsOG003171
Men W, Day 1
ParticipantsOG000207
ParticipantsOG001210
ParticipantsOG0020
ParticipantsOG0030
Men W, Day 31 (Pre vaccination)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002173
ParticipantsOG003187
Men W, Day 31 (Post vaccination)
ParticipantsOG000222
ParticipantsOG001221
ParticipantsOG0020
ParticipantsOG0030
Men W, Day 211 (Post vaccination)
ParticipantsOG000204
ParticipantsOG001213
ParticipantsOG002161
ParticipantsOG003169
Men Y, Day 1
ParticipantsOG000207
ParticipantsOG001211
ParticipantsOG0020
ParticipantsOG0030
Men Y, Day 31 (Pre vaccination)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002175
ParticipantsOG003187
Men Y, Day 31 (Post vaccination)
ParticipantsOG000222
ParticipantsOG001226
ParticipantsOG0020
ParticipantsOG0030
Men Y, Day 211(Post vaccination)
ParticipantsOG000203
ParticipantsOG001214
ParticipantsOG002161
ParticipantsOG003169
OG002
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Units
Counts
Participants
OG000194
OG001201
OG002159
OG003171
OG004186
Title
Denominators
Categories
Men A, Day 31
ParticipantsOG000176
ParticipantsOG001186
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG004180
Title
Measurements
OG00019.1(14.2 to 25.8)
OG00117.0(12.5 to 22.9)
OG00442.9(31.9 to 57.8)
Men A, Day 211
ParticipantsOG000177
ParticipantsOG001181
ParticipantsOG002152
ParticipantsOG003163
Men C, Day 31
ParticipantsOG000193
ParticipantsOG001192
ParticipantsOG0020
ParticipantsOG0030
Men C, Day 211
ParticipantsOG000180
ParticipantsOG001190
ParticipantsOG002156
ParticipantsOG003171
Men W, Day 31
ParticipantsOG000194
ParticipantsOG001195
ParticipantsOG0020
ParticipantsOG0030
Men W, Day 211
ParticipantsOG000178
ParticipantsOG001189
ParticipantsOG002157
ParticipantsOG003167
Men Y, Day 31
ParticipantsOG000193
ParticipantsOG001201
ParticipantsOG0020
ParticipantsOG0030
Men Y, Day 211
ParticipantsOG000177
ParticipantsOG001192
ParticipantsOG002159
ParticipantsOG003167
OG002
ABCWY Low dose_02 Group
Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG003
ABCWY High dose_02 Group
Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
OG004
Control Group
Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).