Efficacy, Safety and Immunogenicity Study of GSK Biologic... | NCT03276962 | Trialant
NCT03276962
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
May 21, 2024Actual
Enrollment
1,500Actual
Phase
Phase 2
Conditions
Malaria
Interventions
RTS,S/AS01E (Full dose)
RTS,S/AS01E (1/5th dose)
Rabies vaccine
Countries
Ghana
Kenya
Protocol Section
Identification Module
NCT ID
NCT03276962
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
204889
Secondary IDs
ID
Type
Description
Link
2016-000290-20
EudraCT Number
Brief Title
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
Official Title
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or With-out Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
May 2024
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
Sep 28, 2017Actual
Primary Completion Date
Nov 4, 2019Actual
Completion Date
Nov 14, 2022Actual
First Submitted Date
Sep 7, 2017
First Submission Date that Met QC Criteria
Sep 7, 2017
First Posted Date
Sep 8, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Oct 31, 2023
Results First Submitted that Met QC Criteria
May 16, 2024
Results First Posted Date
May 21, 2024Actual
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 16, 2024
Last Update Posted Date
May 21, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study intends to establish proof of concept for a fractional dose schedule under conditions of natural exposure in children 5-17 months old at first vaccination. The study also aims to establish the role of third dose spacing in a fractional dose schedule, describe the effect of an earlier full fourth dose at Month 14 and describe the effect of multiple fractional or full yearly doses.
Detailed Description
The current study intends to establish proof of concept (POC) for a fractional dose schedule under conditions of natural exposure. The study will be conducted in children 5-17 months old at first vaccination living in areas of mid to high malaria transmission, in line with the age group recommended by the World Health Organization (WHO) for the implementation of the RTS,S/AS01E vaccine. Results from this study will be critical in informing future possibilities for the development of vaccine-based strategies which, in combination with other interventions, may contribute to the malaria elimination agenda.
Conditions Module
Conditions
Malaria
Keywords
falciparum, efficacy
RTS,S/AS01
malaria vaccine
safety
Malaria
immunogenicity
infants
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,500Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
R012-20 Group
Experimental
Participants will receive a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
Biological: RTS,S/AS01E (Full dose)
R012-14-mD Group
Experimental
Participants will receive a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
Biological: RTS,S/AS01E (Full dose)
Fx012-14-mFxD Group
Experimental
Participants will receive a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
Biological: RTS,S/AS01E (Full dose)
Biological: RTS,S/AS01E (1/5th dose)
Fx017-mFxD Group
Experimental
Participants will receive a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
Biological: RTS,S/AS01E (Full dose)
Biological: RTS,S/AS01E (1/5th dose)
Control Group
Experimental
Participants will receive rabies vaccine at Month 0, Month 1 and Month 2.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RTS,S/AS01E (Full dose)
Biological
Participants will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).
Fx012-14-mFxD Group
Fx017-mFxD Group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence of Clinical Malaria Meeting the Primary Case Definition
The primary case definition is: Plasmodium (P.) falciparum asexual parasitemia greater than (>)5000 parasites/microliters (μl) and presence of fever (axillary temperature greater than or equal to [≥]37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). The objective of this endpoint was to demonstrate the superiority of a Fx012-14-mFxD Group compared to a standard schedule of RTS,S/AS01E with three full doses (R012-20+R012-14 Group) in terms of vaccine efficacy. This analysis was reported for the R012-20+R012-14 Group (Pooled group) because the interventional strategy (1st dose at Month 0, 2nd dose at Month 1, 3rd dose at Month 2) was the same for both the R012-20 group and the R012-14 group until Month 14.
From Month 2.5 to Month 14
Secondary Outcomes
Measure
Description
Time Frame
Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-20 Group
The primary case definition is P. falciparum asexual parasitemia > 5000 μl and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility.
The secondary case definition is P. falciparum asexual parasitemia > 0 and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for primary and secondary case definition is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
Signed or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an independent witness.
A male or female between, and including, five and 17 months of age at the time of the first vaccination.
Healthy participants as established by medical history and clinical examination before entering into the study.
Previously received three documented doses of diphtheria, tetanus, pertussis, hepatitis B vaccine (DTPHepB), and at least three doses of oral polio vaccine.
Exclusion Criteria:
Child in care.
Use of a drug or vaccine that is not approved for that indication (by one of the following regulatory authorities: Food and Drug Administration [FDA; USA] or European Union member state or WHO [with respect to prequalification]) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 0), or planned use during the study period.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (0.5 mg/kg/day (for pediatric participants) or equivalent. Inhaled and topical steroids are allowed.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before each dose and ending seven days after each dose of vaccine administration.
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 vaccine/product (pharmaceutical product or device).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
History of anaphylaxis post-vaccination.
History of any, or documented, serious adverse reaction to rabies vaccination.
Contraindication to rabies vaccination (Rabipur is contraindicated in participants with history of a severe hypersensitivity to any of the ingredients in the vaccine. Note that the vaccine contains polygeline and residues of chicken proteins, and may contain traces of neomycin, chlortetracycline and amphotericin B).
Major congenital defects.
Serious chronic illness.
Children with a past history of a neurological disorder or atypical febrile seizure (a febrile seizure is atypical if it meets one of the following criteria: not associated with fever; lasts > 5 minutes; focal (not generalized); followed by transient or persistent neurological abnormality; occurs in a child < 6 months of age).
Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.
Participants with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
Moderate or severe malnutrition at screening defined as weight for age or weight for height Z-score < -2.
Hemoglobin concentration < 8 g/dl at screening.
Same sex twins (to avoid misidentification).
Maternal death.
Prior receipt of an investigational malaria vaccine.
Westercamp N, Osei-Tutu L, Schuerman L, Kariuki SK, Bollaerts A, Lee CK, Samuels AM, Ockenhouse C, Bii DK, Adjei S, Oneko M, Lievens M, Attobrah Sarfo MA, Atieno C, Bakari A, Sang T, Kotoh-Mortty MF, Otieno K, Roman F, Buabeng PBY, Ntiamoah Y, Ansong D, Agbenyega T, Ofori-Anyinam O. Could Less Be More? Accounting for Fractional-Dose Regimens and Different Number of Vaccine Doses When Measuring the Impact of the RTS,S/AS01E Malaria Vaccine. J Infect Dis. 2024 Aug 16;230(2):e486-e495. doi: 10.1093/infdis/jiae075.
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.
As pre-specified in protocol, efficacy outcome measures corresponding to clinical malaria (primary case definition) and Plasmodium (P.) falciparum infection, presented data for R012-20+R012-14 Group (Pooled group) because the interventional strategy (1st dose at Month 0, 2nd dose at Month 1, 3rd dose at Month 2) was the same for both the R012-20 group and the R012-14 group until Month 14.
Recruitment Details
As pre-specified in statistical analysis plan, data reported in Participant Flow, Baseline Characteristics and Adverse Events were presented for individual groups (R012-20 Group, R012-14-mD Group, R012-14-mD Group, Fx017-mFxD Group and Control Group).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
FG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
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
Nov 14, 2019
Oct 31, 2023
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
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: Rabies vaccine
R012-14-mD Group
R012-20 Group
RTS,S/AS01E (1/5th dose)
Biological
Participants will receive intramuscular injection of RTS,S/AS01E (1/5th dose: 0.1 ml).
Fx012-14-mFxD Group
Fx017-mFxD Group
Rabies vaccine
Biological
Participants will receive intramuscular injection of rabies vaccine (0.1 ml).
Control Group
From Month 0 to Month 50
Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-14-mD Group
The primary case definition is P. falciparum asexual parasitemia > 5000 μl and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility.
The secondary case definition is P. falciparum asexual parasitemia > 0 and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for primary and secondary case definition is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T.
From Month 0 to Month 50
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Prevalence of P. falciparum infections of each RTS,S/AS01E schedule at cross-sectional visits. As specified in the statistical analysis plan, a graphical presentation of the prevalence over time was analyzed for this outcome measure and only the percentage values were reported to depict the prevalence of P. falciparum infections.
Monthly from Month 0 to Month 20 and every 3 months thereafter until Study End (Month 50)
Incidence of P. Falciparum Infections Defined by Positive Blood Slide
The incidence of P. falciparum infections is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T.
Assessment of vaccine efficacy (VE) against first or only episodes of incident P. falciparum infections defined by positive blood slide over the entire study period (Month 0 to Month 50) was not done after the Month 21 Interim analysis since it was assumed that almost all children would have already contracted malaria at least once.
Month 0 to Month 14
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
A seropositive participant is defined as a participant with antibody concentrations ≥ 0.5 ELISA units per milliliter (EU/mL).
Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
A seropositive participant is defined as a participant with antibody concentrations ≥ 10 milli-international units per milliliter (mIU/mL).
Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
Antibody Concentrations for Anti-CS
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as EU/mL.
Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
Antibody Concentrations for Anti-HB
The antibody concentrations were calculated as GMCs and expressed as mlU/mL.
Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs)
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator. Fatal SAEs= Any SAEs leading to death.
From Day 0 to Month 50
Number of Participants With Any Adverse Events (AEs) and SAEs Leading to Withdrawal From Further Vaccination
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
From Day 0 to Month 50
Number of Participants With Cerebral Malaria and Severe Malaria
Cerebral malaria is defined as Severe P. falciparum malaria with coma (Blantyre coma score less than [<] 3); and if malaria with seizure: coma persisting for > 30 min after the seizure. Other treatable causes of coma should be excluded before diagnosing cerebral malaria (e.g. hypoglycaemia, bacterial meningitis).
Severe malaria is defined as P. falciparum parasitemia > 0 detected by microscopy and/or rapid diagnostic test (RDT) and one or more of the following, occurring in the absence of an identified alternative cause: Impaired consciousness, Prostration, Multiple convulsions, Acidosis, Hypoglycemia, Severe malarial anemia, Renal impairment, Jaundice, Pulmonary edema, Significant bleeding: including recurrent or prolonged bleeding from the nose, gums or venipuncture sites, hematemesis or melaena, Shock, Hyperparasitemia.
From Day 0 to Month 50
Number of Participants With Potential Immune Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
From Day 0 to Month 50
Number of Participants With Meningitis
Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
From Day 0 to Month 50
Number of Participants With Seizures
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
During the 30-day (Day 0 to Day 29) follow-up period after any dose of study vaccine
Number of Participants With Generalized Convulsive Seizures
Generalized convulsive seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
During the 7-day (Day 0 to Day 6) follow-up period after any dose of study vaccine
Number of Participants With Any Unsolicited AEs
An unsolicited AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
During the 30-day (Day 0 to Day 29) follow-up period following the 1st 3 doses and post dose 4, 5 and 6 of study vaccine
Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3
The assessed parameters (alanine aminotransferase [ALT], creatinine, haemoglobin, white blood cells [WBC], platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: > 10.0 x ULN (Upper limit of normal), creatine: > 6.0 x ULN or requires dialysis, WBC: < 1.0 x 103 per microliter, platelets: < 25 x 103/μl and clinical signs of bleeding, and hemoglobin: < 5.0 grams/deciliter and clinical signs of heart failure.
Before Dose 3 (at Month 2)
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3
The assessed parameters (ALT, creatinine, haemoglobin, WBC, platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: > 10.0 x ULN, creatine: > 6.0 x ULN or requires dialysis, WBC: < 1.0 x 103 per microliter, platelets: < 25 x 103/μl and clinical signs of bleeding, and hemoglobin: < 5.0 grams/deciliter and clinical signs of heart failure.
At 7 days post-Dose 3
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3
The assessed parameters (ALT, creatinine, haemoglobin, WBC, platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: > 10.0 x ULN, creatine: > 6.0 x ULN or requires dialysis, WBC: < 1.0 x 103 per microliter, platelets: < 25 x 103/μl and clinical signs of bleeding, and hemoglobin: < 5.0 grams/deciliter and clinical signs of heart failure.
At 30 days post-Dose 3
Number of Participants With Any Solicited Local Symptoms
Assessed solicited local AEs are: redness, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any redness and swelling = adverse event reported with a surface diameter > 0 millimeters.
During the 4-day (Day 0 to Day 3) follow-up period after Dose 3, Dose 4, Dose 5 and Dose 6 of study vaccination
Number of Participants With Any Solicited General Symptoms
Assessed solicited general AEs are: drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
During the 4-day (Day 0 to Day 3) follow-up period after Dose 3, Dose 4, Dose 5 and Dose 6 of study vaccination
Kisumu
40100
Kenya
Derived
Osei-Tutu L, Kariuki SK, Lee CK, Fabre R, Bii DK, Adjei S, Oneko M, Attobrah Sarfo MA, Ockenhouse CF, Schuerman L, Buabeng PBY, Bakari A, Atieno C, Kotoh-Mortty MF, Otieno K, Ntiamoah Y, Sang T, Bollaerts A, Westercamp N, Ansong D, Agbenyega T, Samuels AM, Ofori-Anyinam O; RTS,S study group. Sustained efficacy of the RTS,S/AS01E malaria vaccine over 50 months of follow-up when used in full-dose or fractional-dose regimens in young children in Ghana and Kenya: final results from an open-label, phase 2b, randomised controlled trial. Lancet Glob Health. 2025 Oct;13(10):e1723-e1736. doi: 10.1016/S2214-109X(25)00272-4.
Juraska M, Early AM, Li L, Schaffner SF, Lievens M, Khorgade A, Simpkins B, Hejazi NS, Benkeser D, Wang Q, Mercer LD, Adjei S, Agbenyega T, Anderson S, Ansong D, Bii DK, Buabeng PBY, English S, Fitzgerald N, Grimsby J, Kariuki SK, Otieno K, Roman F, Samuels AM, Westercamp N, Ockenhouse CF, Ofori-Anyinam O, Lee CK, MacInnis BL, Wirth DF, Gilbert PB, Neafsey DE. Genotypic analysis of RTS,S/AS01E malaria vaccine efficacy against parasite infection as a function of dosage regimen and baseline malaria infection status in children aged 5-17 months in Ghana and Kenya: a longitudinal phase 2b randomised controlled trial. Lancet Infect Dis. 2024 Sep;24(9):1025-1036. doi: 10.1016/S1473-3099(24)00179-8. Epub 2024 May 6.
Juraska M, Early AM, Li L, Schaffner SF, Lievens M, Khorgade A, Simpkins B, Hejazi NS, Benkeser DA, Wang Q, Mercer LD, Adjei S, Agbenyega T, Anderson S, Ansong D, Bii DK, Buabeng PBY, English S, Fitzgerald N, Grimsby J, Kariuki SK, Otieno K, Roman F, Samuels AM, Westercamp N, Ockenhouse CF, Ofori-Anyinam O, Lee CK, MacInnis BL, Wirth DF, Gilbert PB, Neafsey DE. Baseline malaria infection status and RTS,S/AS01E malaria vaccine efficacy. medRxiv [Preprint]. 2023 Nov 23:2023.11.22.23298907. doi: 10.1101/2023.11.22.23298907.
Samuels AM, Ansong D, Kariuki SK, Adjei S, Bollaerts A, Ockenhouse C, Westercamp N, Lee CK, Schuerman L, Bii DK, Osei-Tutu L, Oneko M, Lievens M, Attobrah Sarfo MA, Atieno C, Morelle D, Bakari A, Sang T, Jongert E, Kotoh-Mortty MF, Otieno K, Roman F, Buabeng PBY, Ntiamoah Y, Ofori-Anyinam O, Agbenyega T; RTS,S study group. Efficacy of RTS,S/AS01E malaria vaccine administered according to different full, fractional, and delayed third or early fourth dose regimens in children aged 5-17 months in Ghana and Kenya: an open-label, phase 2b, randomised controlled trial. Lancet Infect Dis. 2022 Sep;22(9):1329-1342. doi: 10.1016/S1473-3099(22)00273-0. Epub 2022 Jun 23.
FG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
FG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
FG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
FG000298 subjects
FG001294 subjects
FG002304 subjects
FG003311 subjects
FG004293 subjects
COMPLETED
FG000229 subjects
FG001232 subjects
FG002242 subjects
FG003247 subjects
FG004237 subjects
NOT COMPLETED
FG00069 subjects
FG00162 subjects
FG00262 subjects
FG00364 subjects
FG00456 subjects
Type
Comment
Reasons
Serious Adverse Event And/Or Pimd
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0034 subjects
FG0041 subjects
Protocol Deviation
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Consent Withdrawal, Not Due To An Adverse Event/A Serious Adverse Event
FG00029 subjects
FG00121 subjects
FG00213 subjects
FG00321 subjects
Migrated / Moved From The Study Area
FG00026 subjects
FG00128 subjects
FG00244 subjects
FG00329 subjects
FG004
Lost to Follow-up
FG00010 subjects
FG00110 subjects
FG0024 subjects
FG0036 subjects
FG004
Other
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
BG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
BG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
BG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
BG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000298
BG001294
BG002304
BG003311
BG004293
BG0051500
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
Months
Title
Denominators
Categories
Title
Measurements
BG00010.2± 3.9
BG00110.3± 3.8
BG00210.5± 4.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000119
BG001155
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Black Or African American
Title
Measurements
BG000298
BG001294
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
Incidence of Clinical Malaria Meeting the Primary Case Definition
The primary case definition is: Plasmodium (P.) falciparum asexual parasitemia greater than (>)5000 parasites/microliters (μl) and presence of fever (axillary temperature greater than or equal to [≥]37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). The objective of this endpoint was to demonstrate the superiority of a Fx012-14-mFxD Group compared to a standard schedule of RTS,S/AS01E with three full doses (R012-20+R012-14 Group) in terms of vaccine efficacy. This analysis was reported for the R012-20+R012-14 Group (Pooled group) because the interventional strategy (1st dose at Month 0, 2nd dose at Month 1, 3rd dose at Month 2) was the same for both the R012-20 group and the R012-14 group until Month 14.
This analysis was performed on Per Protocol Set (PPS) for efficacy, which included all participants from Exposed Set (ES) who fulfilled eligibility criteria and received all interventions as per study plan, within the protocol specified intervals that contribute to the time at risk in the follow-up period starting Month 2.5 to Month 14. As pre-specified in the analysis plan, the analysis of this outcome measure was reported for the R012-20+R012-14 Group and the Fx012-14-mFxD Group.
Posted
Number
events per person-year
From Month 2.5 to Month 14
ID
Title
Description
OG000
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG001
R012-20 + R012-14 Group
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
Units
Counts
Participants
OG000271
OG001523
Title
Denominators
Categories
Title
Measurements
OG0000.45
OG0010.36
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To demonstrate the superiority of a 3-dose schedule of GSK Biologicals' malaria vaccine RTS,S/AS01E with a fractional third dose at Month 2 (Fx012-14-mFxD Group) compared to a standard schedule of RTS,S/AS01E with 3 full doses (R012-20 + R012-14 Group) in terms of vaccine efficacy against clinical malaria (primary case definition) over 12 months post-Dose 3.
Regression, Cox
The 95% Confidence Interval of the incremental vaccine efficacy estimates was calculated from Cox regression model.
0.154
Incremental vaccine efficacy
-21
2-Sided
95
-57
7
Superiority
Secondary
Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-20 Group
The primary case definition is P. falciparum asexual parasitemia > 5000 μl and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility.
The secondary case definition is P. falciparum asexual parasitemia > 0 and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for primary and secondary case definition is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine. As per statistical analysis plan, the analysis of this outcome measure was reported only for the Fx012-14-mFxD Group and the R012-20 Group since the objective of this endpoint was to assess the vaccine efficacy in terms of incident rate against Fx012-14-mFxD Group versus R012-20 Group.
Posted
Number
events per person-year
From Month 0 to Month 50
ID
Title
Description
OG000
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG001
Secondary
Incidence of Clinical Malaria Meeting the Primary and Secondary Case Definitions of the Fx012-14-mFxD Group Versus the R012-14-mD Group
The primary case definition is P. falciparum asexual parasitemia > 5000 μl and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility.
The secondary case definition is P. falciparum asexual parasitemia > 0 and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who is unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for primary and secondary case definition is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine. As per statistical analysis plan, the analysis of this outcome measure was reported only for the Fx012-14-mFxD Group and the R012-14-mD Group since the objective of this endpoint was to assess the vaccine efficacy in terms of incident rate against Fx012-14-mFxD Group versus R012-14-mD Group..
Posted
Number
events per person-year
From Month 0 to Month 50
ID
Title
Description
OG000
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG001
Secondary
The Prevalence of P. Falciparum Infections Defined by Positive Blood Slide at Each Cross-sectional Survey
Prevalence of P. falciparum infections of each RTS,S/AS01E schedule at cross-sectional visits. As specified in the statistical analysis plan, a graphical presentation of the prevalence over time was analyzed for this outcome measure and only the percentage values were reported to depict the prevalence of P. falciparum infections.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine and for whom data were assessed during specific timepoints.
Posted
Number
Percentage of participants
Monthly from Month 0 to Month 20 and every 3 months thereafter until Study End (Month 50)
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
Secondary
Incidence of P. Falciparum Infections Defined by Positive Blood Slide
The incidence of P. falciparum infections is expressed as n/T, representing the n reported over the risk period, which was counted in days and expressed as T.
Assessment of vaccine efficacy (VE) against first or only episodes of incident P. falciparum infections defined by positive blood slide over the entire study period (Month 0 to Month 50) was not done after the Month 21 Interim analysis since it was assumed that almost all children would have already contracted malaria at least once.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine and for whom data were collected from Month 0 to Month 14. As pre-specified in the analysis plan, the analysis of the outcome measure was reported for the R012-20+R012-14 Group (Pooled group) because the interventional strategy (1st dose at Month 0, 2nd dose at Month 1 and 3rd dose at Month 2) was the same for both the R012-20 group and the R012-14 group until Month 14.
Posted
Number
events per person-year
Month 0 to Month 14
ID
Title
Description
OG000
R012-20 + R012-14 Group
Participants received full doses of RTS,S/AS01E at Month 0, Month 1, Month 2 and a full dose at Month 14, Month 20, Month 26, Month 38.
OG001
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
Secondary
Number of Seropositive Participants for Anti-circumsporozoite (Anti-CS) Antibodies
A seropositive participant is defined as a participant with antibody concentrations ≥ 0.5 ELISA units per milliliter (EU/mL).
The analysis was performed on immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
Posted
Count of Participants
Participants
Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
Secondary
Number of Seropositive Participants for Anti-hepatitis B (Anti-HB) Antibodies
A seropositive participant is defined as a participant with antibody concentrations ≥ 10 milli-international units per milliliter (mIU/mL).
The analysis was performed on the immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
Posted
Count of Participants
Participants
Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
Secondary
Antibody Concentrations for Anti-CS
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as EU/mL.
The analysis was performed on the immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
Secondary
Antibody Concentrations for Anti-HB
The antibody concentrations were calculated as GMCs and expressed as mlU/mL.
The analysis was performed on immunosubset which included all participants who complied with protocol defined procedures and for whom immunogenicity results were available for the specified time point and specific assay.
Posted
Geometric Mean
95% Confidence Interval
mlU/mL
Before Dose 1, one month post-Dose 2, before and one month post-Dose 3, before and one month after Dose 4, before and one month after each yearly dose and at Study End (Month 50)
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG003
Secondary
Number of Participants With Any, Fatal and Related Serious Adverse Events (SAEs)
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator. Fatal SAEs= Any SAEs leading to death.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Posted
Count of Participants
Participants
From Day 0 to Month 50
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
Secondary
Number of Participants With Any Adverse Events (AEs) and SAEs Leading to Withdrawal From Further Vaccination
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Posted
Count of Participants
Participants
From Day 0 to Month 50
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
Secondary
Number of Participants With Cerebral Malaria and Severe Malaria
Cerebral malaria is defined as Severe P. falciparum malaria with coma (Blantyre coma score less than [<] 3); and if malaria with seizure: coma persisting for > 30 min after the seizure. Other treatable causes of coma should be excluded before diagnosing cerebral malaria (e.g. hypoglycaemia, bacterial meningitis).
Severe malaria is defined as P. falciparum parasitemia > 0 detected by microscopy and/or rapid diagnostic test (RDT) and one or more of the following, occurring in the absence of an identified alternative cause: Impaired consciousness, Prostration, Multiple convulsions, Acidosis, Hypoglycemia, Severe malarial anemia, Renal impairment, Jaundice, Pulmonary edema, Significant bleeding: including recurrent or prolonged bleeding from the nose, gums or venipuncture sites, hematemesis or melaena, Shock, Hyperparasitemia.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Posted
Count of Participants
Participants
From Day 0 to Month 50
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
Secondary
Number of Participants With Potential Immune Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Posted
Count of Participants
Participants
From Day 0 to Month 50
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG003
Fx017-mFxD Group
Secondary
Number of Participants With Meningitis
Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Posted
Count of Participants
Participants
From Day 0 to Month 50
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
Secondary
Number of Participants With Seizures
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Posted
Count of Participants
Participants
During the 30-day (Day 0 to Day 29) follow-up period after any dose of study vaccine
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG003
Fx017-mFxD Group
Secondary
Number of Participants With Generalized Convulsive Seizures
Generalized convulsive seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine.
Posted
Count of Participants
Participants
During the 7-day (Day 0 to Day 6) follow-up period after any dose of study vaccine
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG003
Fx017-mFxD Group
Secondary
Number of Participants With Any Unsolicited AEs
An unsolicited AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
The analysis was performed on ES which included all participants who received at least one dose of study vaccine and who had safety data available for the specific duration.
Posted
Count of Participants
Participants
During the 30-day (Day 0 to Day 29) follow-up period following the 1st 3 doses and post dose 4, 5 and 6 of study vaccine
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
Secondary
Number of Participants With Grade 4 Hematology and Biochemical Toxicities Before Dose 3
The assessed parameters (alanine aminotransferase [ALT], creatinine, haemoglobin, white blood cells [WBC], platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: > 10.0 x ULN (Upper limit of normal), creatine: > 6.0 x ULN or requires dialysis, WBC: < 1.0 x 103 per microliter, platelets: < 25 x 103/μl and clinical signs of bleeding, and hemoglobin: < 5.0 grams/deciliter and clinical signs of heart failure.
The analysis was performed on the reactogenicity sub-cohort, which included the first 50 participants enrolled in each group and for whom specific lab parameter data was available at a specific timepoint.
Posted
Count of Participants
Participants
Before Dose 3 (at Month 2)
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Secondary
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 7 Days Post-Dose 3
The assessed parameters (ALT, creatinine, haemoglobin, WBC, platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: > 10.0 x ULN, creatine: > 6.0 x ULN or requires dialysis, WBC: < 1.0 x 103 per microliter, platelets: < 25 x 103/μl and clinical signs of bleeding, and hemoglobin: < 5.0 grams/deciliter and clinical signs of heart failure.
The analysis was performed on the reactogenicity sub-cohort, which included the first 50 participants enrolled in each group and for whom specific lab parameter data was available at a specific timepoint.
Posted
Count of Participants
Participants
At 7 days post-Dose 3
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Secondary
Number of Participants With Grade 4 Hematology and Biochemical Toxicities at 30 Days Post-Dose 3
The assessed parameters (ALT, creatinine, haemoglobin, WBC, platelets) were summarized according to DAIDS, 2004 (Division of AIDS). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included ALT: > 10.0 x ULN, creatine: > 6.0 x ULN or requires dialysis, WBC: < 1.0 x 103 per microliter, platelets: < 25 x 103/μl and clinical signs of bleeding, and hemoglobin: < 5.0 grams/deciliter and clinical signs of heart failure.
The analysis was performed on the reactogenicity sub-cohort, which included the first 50 participants enrolled in each group and for whom specific lab parameter data was available at a specific timepoint.
Posted
Count of Participants
Participants
At 30 days post-Dose 3
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Secondary
Number of Participants With Any Solicited Local Symptoms
Assessed solicited local AEs are: redness, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any redness and swelling = adverse event reported with a surface diameter > 0 millimeters.
The analysis was performed on Solicited Safety Set reactogenicity sub-cohort (SSRS) which included all participants who received at least one dose of study vaccine and had solicited local data during specific duration.
Posted
Count of Participants
Participants
During the 4-day (Day 0 to Day 3) follow-up period after Dose 3, Dose 4, Dose 5 and Dose 6 of study vaccination
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
Secondary
Number of Participants With Any Solicited General Symptoms
Assessed solicited general AEs are: drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
The analysis was performed on SSRS which included all participants who received at least one dose of study vaccine and had solicited general data during specific duration.
Posted
Count of Participants
Participants
During the 4-day (Day 0 to Day 3) follow-up period after Dose 3, Dose 4, Dose 5 and Dose 6 of study vaccination
ID
Title
Description
OG000
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
OG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG003
Time Frame
Serious Adverse Events: From Month 0 to Month 50. All-Cause Mortality: From Month 0 to Month 50. Other Adverse Events: Solicited Adverse Events were collected during the 4-day follow-up period after vaccination and Unsolicited Adverse Events during the 30-day follow-up period after vaccination
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
R012-20 Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
2
298
73
298
230
298
EG001
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
1
294
65
294
243
294
EG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
0
304
64
304
253
304
EG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
4
311
84
311
253
311
EG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
1
293
92
293
234
293
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Plasmodium falciparum infection
Infections and infestations
Systematic Assessment
EG00028 events28 affected298 at risk
EG00122 events22 affected294 at risk
EG00229 events29 affected304 at risk
EG00332 events32 affected311 at risk
EG00448 events48 affected293 at risk
Pneumonia
Infections and infestations
Systematic Assessment
EG00015 events15 affected298 at risk
EG00115 events15 affected294 at risk
EG00212 events12 affected304 at risk
EG003
Gastroenteritis
Infections and infestations
Systematic Assessment
EG00012 events12 affected298 at risk
EG0019 events9 affected294 at risk
EG0029 events9 affected304 at risk
EG003
Malaria
Infections and infestations
Systematic Assessment
EG0008 events8 affected298 at risk
EG0017 events7 affected294 at risk
EG0026 events6 affected304 at risk
EG003
Otitis media
Infections and infestations
Systematic Assessment
EG0004 events4 affected298 at risk
EG0013 events3 affected294 at risk
EG0024 events4 affected304 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0003 events3 affected298 at risk
EG0011 events1 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Cellulitis
Infections and infestations
Systematic Assessment
EG0003 events3 affected298 at risk
EG0012 events2 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Abscess limb
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Meningitis viral
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Otitis media acute
Infections and infestations
Systematic Assessment
EG0003 events3 affected298 at risk
EG0011 events1 affected294 at risk
EG0023 events3 affected304 at risk
EG003
Subcutaneous abscess
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0023 events3 affected304 at risk
EG003
Dysentery
Infections and infestations
Systematic Assessment
EG0002 events2 affected298 at risk
EG0010 events0 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Bacterial infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Periorbital cellulitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0012 events2 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Skin bacterial infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0012 events2 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Bronchiolitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Lower respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Meningitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Abscess neck
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Cellulitis orbital
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Conjunctivitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Pneumonia aspiration
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Pyomyositis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Acarodermatitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Amoebic dysentery
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Arthritis bacterial
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Bullous impetigo
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Cerebral malaria
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Ear infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Encephalitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Fungal skin infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Joint abscess
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Klebsiella sepsis
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Mastoid abscess
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Mastoiditis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Meningitis enteroviral
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Postoperative wound infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Salmonella sepsis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Sinusitis bacterial
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Superinfection bacterial
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Tinea capitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Tooth abscess
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Typhoid fever
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Febrile convulsion
Nervous system disorders
Systematic Assessment
EG00010 events10 affected298 at risk
EG0014 events4 affected294 at risk
EG0026 events6 affected304 at risk
EG003
Seizure
Nervous system disorders
Systematic Assessment
EG0003 events3 affected298 at risk
EG0012 events2 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Tonic convulsion
Nervous system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0005 events5 affected298 at risk
EG0014 events4 affected294 at risk
EG0024 events4 affected304 at risk
EG003
Intravascular haemolysis
Blood and lymphatic system disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Hypersplenism
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Abdominal lymphadenopathy
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Sickle cell anaemia with crisis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected298 at risk
EG0013 events3 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Exposure to toxic agent
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Head injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Burns first degree
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Electric shock
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Eyelid abrasion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Fall
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Foreign body in gastrointestinal tract
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Foreign body in mouth
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Hyphaema
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Limb traumatic amputation
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Gastritis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Intussusception
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Anal skin tags
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Inguinal hernia strangulated
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Strangulated umbilical hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Acute chest syndrome
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Acute kidney injury
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Urethral polyp
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Urethral prolapse
Renal and urinary disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Cryptorchism
Congenital, familial and genetic disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Drowning
General disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Hernia
General disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Fracture malunion
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Tympanic membrane perforation
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Allergy to arthropod sting
Immune system disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Testicular retraction
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Hypovolaemic shock
Vascular disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG000238 events161 affected298 at risk
EG001320 events187 affected294 at risk
EG002377 events198 affected304 at risk
EG003323 events194 affected311 at risk
EG004237 events164 affected293 at risk
Malaria
Infections and infestations
Systematic Assessment
EG000101 events76 affected298 at risk
EG001142 events86 affected294 at risk
EG002147 events98 affected304 at risk
EG003
Gastroenteritis
Infections and infestations
Systematic Assessment
EG00065 events56 affected298 at risk
EG001107 events87 affected294 at risk
EG00295 events76 affected304 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG00020 events19 affected298 at risk
EG00144 events41 affected294 at risk
EG00242 events38 affected304 at risk
EG003
Conjunctivitis
Infections and infestations
Systematic Assessment
EG00026 events24 affected298 at risk
EG00135 events32 affected294 at risk
EG00237 events35 affected304 at risk
EG003
Otitis media
Infections and infestations
Systematic Assessment
EG00025 events23 affected298 at risk
EG00129 events25 affected294 at risk
EG00237 events33 affected304 at risk
EG003
Skin bacterial infection
Infections and infestations
Systematic Assessment
EG00020 events18 affected298 at risk
EG00129 events25 affected294 at risk
EG00235 events29 affected304 at risk
EG003
Respiratory tract infection
Infections and infestations
Systematic Assessment
EG00019 events18 affected298 at risk
EG00116 events15 affected294 at risk
EG00216 events16 affected304 at risk
EG003
Rash pustular
Infections and infestations
Systematic Assessment
EG0009 events9 affected298 at risk
EG00112 events12 affected294 at risk
EG00213 events11 affected304 at risk
EG003
Body tinea
Infections and infestations
Systematic Assessment
EG0004 events4 affected298 at risk
EG00112 events11 affected294 at risk
EG00211 events11 affected304 at risk
EG003
Septic rash
Infections and infestations
Systematic Assessment
EG00012 events10 affected298 at risk
EG00111 events9 affected294 at risk
EG00210 events10 affected304 at risk
EG003
Tinea capitis
Infections and infestations
Systematic Assessment
EG0008 events8 affected298 at risk
EG00110 events9 affected294 at risk
EG0028 events8 affected304 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0006 events6 affected298 at risk
EG0019 events8 affected294 at risk
EG0027 events7 affected304 at risk
EG003
Oral candidiasis
Infections and infestations
Systematic Assessment
EG0006 events6 affected298 at risk
EG0015 events5 affected294 at risk
EG0023 events2 affected304 at risk
EG003
Lower respiratory tract infection
Infections and infestations
Systematic Assessment
EG0004 events4 affected298 at risk
EG0015 events5 affected294 at risk
EG0024 events4 affected304 at risk
EG003
Abscess
Infections and infestations
Systematic Assessment
EG0006 events6 affected298 at risk
EG0014 events4 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Dysentery
Infections and infestations
Systematic Assessment
EG0002 events2 affected298 at risk
EG0014 events4 affected294 at risk
EG0025 events5 affected304 at risk
EG003
Tonsillitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0015 events5 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Rhinitis
Infections and infestations
Systematic Assessment
EG0003 events3 affected298 at risk
EG0015 events5 affected294 at risk
EG0023 events3 affected304 at risk
EG003
Viral infection
Infections and infestations
Systematic Assessment
EG0003 events3 affected298 at risk
EG0012 events2 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Wound sepsis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0012 events2 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Acarodermatitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0012 events2 affected294 at risk
EG0025 events5 affected304 at risk
EG003
Helminthic infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0013 events3 affected294 at risk
EG0024 events4 affected304 at risk
EG003
Otitis externa
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0023 events3 affected304 at risk
EG003
Furuncle
Infections and infestations
Systematic Assessment
EG0004 events4 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Cellulitis
Infections and infestations
Systematic Assessment
EG0002 events2 affected298 at risk
EG0011 events1 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Viral rash
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Bacterial infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Otitis media acute
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Varicella
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Abscess limb
Infections and infestations
Systematic Assessment
EG0002 events2 affected298 at risk
EG0010 events0 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Fungal skin infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Cutaneous larva migrans
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Skin infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Subcutaneous abscess
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Tinea pedis
Infections and infestations
Systematic Assessment
EG0002 events2 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Bullous impetigo
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0012 events2 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Ear infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Hordeolum
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Conjunctivitis viral
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Dermatitis infected
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Ecthyma
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Fungal infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Gastroenteritis cryptosporidial
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Impetigo
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Joint abscess
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Measles
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Mumps
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Otitis media chronic
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Pharyngotonsillitis
Infections and infestations
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Plasmodium falciparum infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Pyomyositis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Sinusitis bacterial
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Superinfection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Taeniasis
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Varicella zoster virus infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG00027 events26 affected298 at risk
EG00135 events30 affected294 at risk
EG00228 events27 affected304 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 events2 affected298 at risk
EG0017 events6 affected294 at risk
EG0023 events3 affected304 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 events2 affected298 at risk
EG00110 events10 affected294 at risk
EG0023 events3 affected304 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0013 events3 affected294 at risk
EG0023 events3 affected304 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0005 events4 affected298 at risk
EG0011 events1 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 events2 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0012 events2 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0013 events3 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0022 events1 affected304 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG00041 events35 affected298 at risk
EG001103 events69 affected294 at risk
EG00243 events36 affected304 at risk
EG003
Injection site pain
General disorders
Systematic Assessment
EG0004 events4 affected298 at risk
EG00112 events9 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Injection site swelling
General disorders
Systematic Assessment
EG0003 events3 affected298 at risk
EG0015 events4 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Irritability postvaccinal
General disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0017 events6 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Chest pain
General disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Injection site erythema
General disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Peripheral swelling
General disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Swelling
General disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Xerosis
General disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG00034 events30 affected298 at risk
EG00126 events25 affected294 at risk
EG00244 events40 affected304 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0006 events6 affected298 at risk
EG0013 events3 affected294 at risk
EG0028 events7 affected304 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0012 events2 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Stomatitis
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected298 at risk
EG0012 events2 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Enteritis
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Gastritis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0012 events2 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Rectal prolapse
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG00012 events12 affected298 at risk
EG0019 events9 affected294 at risk
EG00211 events10 affected304 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG00010 events8 affected298 at risk
EG0018 events8 affected294 at risk
EG00214 events12 affected304 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0022 events2 affected304 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Allergic cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
Systematic Assessment
EG0002 events2 affected298 at risk
EG0012 events2 affected294 at risk
EG0024 events4 affected304 at risk
EG003
Wound
Injury, poisoning and procedural complications
Systematic Assessment
EG0002 events2 affected298 at risk
EG0013 events3 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0012 events2 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Animal scratch
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Burns first degree
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Chemical burns of eye
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Foreign body in respiratory tract
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Lip injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Tooth injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0002 events2 affected298 at risk
EG0019 events9 affected294 at risk
EG0027 events7 affected304 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Conjunctivitis allergic
Eye disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0014 events4 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Vernal keratoconjunctivitis
Eye disorders
Systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Eye allergy
Eye disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Somnolence
Nervous system disorders
Systematic Assessment
EG0002 events2 affected298 at risk
EG0012 events2 affected294 at risk
EG0023 events2 affected304 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 at risk
EG003
Ear pain
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Irritability
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0013 events2 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Blood creatinine increased
Investigations
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected304 at risk
EG003
Bone swelling
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected304 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 a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.
Units
Counts
Participants
OG000304
OG001298
Title
Denominators
Categories
Primary case definition
Title
Measurements
OG0000.69
OG0010.86
Secondary case definition
Title
Measurements
OG0001.18
OG0011.62
R012-14-mD Group
Participants received a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.
Units
Counts
Participants
OG000304
OG001294
Title
Denominators
Categories
Primary case definition
Title
Measurements
OG0000.69
OG0010.67
Secondary case definition
Title
Measurements
OG0001.18
OG0011.22
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG000298
OG001294
OG002304
OG003311
OG004293
Title
Denominators
Categories
Month 0
Title
Measurements
OG00010.1
OG0016.1
OG0024.6
OG0035.1
OG0047.2
Month 1
Title
Measurements
OG0003.8
OG0015.9
OG0023.1
OG003
Month 2
Title
Measurements
OG0004.3
OG0014.6
OG0022.8
OG003
Month 3
Title
Measurements
OG0003.0
OG0014.1
OG0023.2
OG003
Month 4
Title
Measurements
OG0003.9
OG0014.7
OG0022.3
OG003
Month 5
Title
Measurements
OG0003.9
OG0013.6
OG0021.9
OG003
Month 6
Title
Measurements
OG0004.8
OG0014.4
OG0023.0
OG003
Month 7
Title
Measurements
OG0006.0
OG0017.7
OG0026.5
OG003
Month 8
Title
Measurements
OG0004.0
OG0017.2
OG0025.0
OG003
Month 9
Title
Measurements
OG0006.7
OG0016.6
OG0026.8
OG003
Month 10
Title
Measurements
OG0006.0
OG0015.3
OG0027.4
OG003
Month 11
Title
Measurements
OG0008.4
OG0015.7
OG0026.9
OG003
Month 12
Title
Measurements
OG0009.7
OG0016.5
OG0026.9
OG003
Month 13
Title
Measurements
OG0007.3
OG0016.9
OG0027.7
OG003
Month 14
Title
Measurements
OG00012.6
OG0012.0
OG0025.3
OG003
Month 15
Title
Measurements
OG0008.3
OG0013.7
OG0025.1
OG003
Month 16
Title
Measurements
OG0007.9
OG0016.7
OG0026.8
OG003
Month 17
Title
Measurements
OG00010.8
OG0019.8
OG0027.0
OG003
Month 18
Title
Measurements
OG0009.3
OG0019.9
OG0027.1
OG003
Month 19
Title
Measurements
OG0006.8
OG0017.9
OG0028.8
OG003
Month 20
Title
Measurements
OG0007.0
OG0018.3
OG0028.1
OG003
Month 23
Title
Measurements
OG00011.3
OG0017.3
OG00211.2
OG003
Month 26
Title
Measurements
OG00012.2
OG0012.8
OG0026.0
OG003
Month 29
Title
Measurements
OG00010.6
OG0016.9
OG0029.2
OG003
Month 32
Title
Measurements
OG00010.5
OG0017.9
OG0027.9
OG003
Month 35
Title
Measurements
OG00010.9
OG00111.0
OG00210.1
OG003
Month 38
Title
Measurements
OG00011.5
OG0016.5
OG0027.3
OG003
Month 41
Title
Measurements
OG0005.8
OG0017.5
OG0026.8
OG003
Month 44
Title
Measurements
OG00012.3
OG00110.2
OG0029.8
OG003
Month 47
Title
Measurements
OG00013.8
OG0015.7
OG0028.9
OG003
Month 50
Title
Measurements
OG00013.1
OG00110.8
OG00213.6
OG003
OG002
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG003
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG000543
OG001290
OG002295
OG003272
Title
Denominators
Categories
Title
Measurements
OG0000.50
OG0010.60
OG0020.59
OG0030.80
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG00045
OG00149
OG00245
OG00349
OG00448
Title
Denominators
Categories
Before Dose 1, Pre-Vaccination (Day 1)
ParticipantsOG00045
ParticipantsOG00149
ParticipantsOG00245
ParticipantsOG00349
ParticipantsOG00448
Title
Measurements
OG0002
OG0011
OG0020
OG003
Post Dose 2 (Month 2)
ParticipantsOG00043
ParticipantsOG00148
ParticipantsOG00242
ParticipantsOG00348
Post Dose 3 (Month 3)
ParticipantsOG00036
ParticipantsOG00144
ParticipantsOG00241
ParticipantsOG0030
Pre-Dose 3 (Month 7)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00344
Post Dose 3 (Month 8)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00343
Pre-Dose 4 (Month 14)
ParticipantsOG0000
ParticipantsOG00142
ParticipantsOG00240
ParticipantsOG0030
Post Dose 4 (Month 15)
ParticipantsOG0000
ParticipantsOG00137
ParticipantsOG00238
ParticipantsOG0030
Pre-Dose 4 (Month 20)
ParticipantsOG00037
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00342
Post Dose 4 (Month 21)
ParticipantsOG00035
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00339
Pre-Dose 5 (Month 26)
ParticipantsOG0000
ParticipantsOG00138
ParticipantsOG00234
ParticipantsOG0030
Post Dose 5 (Month 27)
ParticipantsOG0000
ParticipantsOG00130
ParticipantsOG00226
ParticipantsOG0030
Pre-Dose 5 (Month 32)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00337
Post Dose 5 (Month 33)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00332
Pre-Dose 6 (Month 38)
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG00231
ParticipantsOG0030
Post Dose 6 (Month 39)
ParticipantsOG0000
ParticipantsOG00133
ParticipantsOG00228
ParticipantsOG0030
End of Study (Month 50)
ParticipantsOG00030
ParticipantsOG00134
ParticipantsOG00229
ParticipantsOG00325
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG00045
OG00149
OG00244
OG00348
OG00448
Title
Denominators
Categories
Before Dose 1, Pre-Vaccination (Day 1)
ParticipantsOG00045
ParticipantsOG00149
ParticipantsOG00244
ParticipantsOG00348
ParticipantsOG00448
Title
Measurements
OG00042
OG00148
OG00239
OG003
Post Dose 2 (Month 2)
ParticipantsOG00043
ParticipantsOG00148
ParticipantsOG00241
ParticipantsOG00348
Post Dose 3 (Month 3)
ParticipantsOG00035
ParticipantsOG00144
ParticipantsOG00240
ParticipantsOG0030
Pre-Dose 3 (Month 7)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00344
Post Dose 3 (Month 8)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00343
Pre-Dose 4 (Month 14)
ParticipantsOG0000
ParticipantsOG00141
ParticipantsOG00240
ParticipantsOG0030
Post Dose 4 (Month 15)
ParticipantsOG0000
ParticipantsOG00137
ParticipantsOG00237
ParticipantsOG0030
Pre-Dose 4 (Month 20)
ParticipantsOG00037
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00342
Post Dose 4 (Month 21)
ParticipantsOG00033
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00338
Pre-Dose 5 (Month 26)
ParticipantsOG0000
ParticipantsOG00138
ParticipantsOG00234
ParticipantsOG0030
Post Dose 5 (Month 27)
ParticipantsOG0000
ParticipantsOG00130
ParticipantsOG00226
ParticipantsOG0030
Pre-Dose 5 (Month 32)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00337
Post Dose 5 (Month 33)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00332
Pre-Dose 6 (Month 38)
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG00231
ParticipantsOG0030
Post Dose 6 (Month 39)
ParticipantsOG0000
ParticipantsOG00133
ParticipantsOG00228
ParticipantsOG0030
End of Study (Month 50)
ParticipantsOG00030
ParticipantsOG00134
ParticipantsOG00228
ParticipantsOG00325
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG00045
OG00149
OG00245
OG00349
OG00448
Title
Denominators
Categories
Before Dose 1, Pre-Vaccination (Day 1)
ParticipantsOG00045
ParticipantsOG00149
ParticipantsOG00245
ParticipantsOG00349
ParticipantsOG00448
Title
Measurements
OG0001.0(0.9 to 1.0)
OG0011.0(0.9 to 1.0)
OG0021.0(1.0 to 1.0)
OG003
Post Dose 2 (Month 2)
ParticipantsOG00043
ParticipantsOG00148
ParticipantsOG00242
ParticipantsOG00348
Post Dose 3 (Month 3)
ParticipantsOG00036
ParticipantsOG00144
ParticipantsOG00241
ParticipantsOG0030
Pre-Dose 3 (Month 7)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00344
Post Dose 3 (Month 8)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00343
Pre-Dose 4 (Month 14)
ParticipantsOG0000
ParticipantsOG00142
ParticipantsOG00240
ParticipantsOG0030
Post Dose 4 (Month 15)
ParticipantsOG0000
ParticipantsOG00137
ParticipantsOG00238
ParticipantsOG0030
Pre-Dose 4 (Month 20)
ParticipantsOG00037
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00342
Post Dose 4 (Month 21)
ParticipantsOG00035
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00339
Pre-Dose 5 (Month 26)
ParticipantsOG0000
ParticipantsOG00138
ParticipantsOG00234
ParticipantsOG0030
Post Dose 5 (Month 27)
ParticipantsOG0000
ParticipantsOG00130
ParticipantsOG00226
ParticipantsOG0030
Pre-Dose 5 (Month 32)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00337
Post Dose 5 (Month 33)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00332
Pre-Dose 6 (Month 38)
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG00231
ParticipantsOG0030
Post Dose 6 (Month 39)
ParticipantsOG0000
ParticipantsOG00133
ParticipantsOG00228
ParticipantsOG0030
End of Study (Month 50)
ParticipantsOG00030
ParticipantsOG00134
ParticipantsOG00229
ParticipantsOG00325
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG00045
OG00149
OG00244
OG00348
OG00448
Title
Denominators
Categories
Before Dose 1, Pre-Vaccination (Day 1)
ParticipantsOG00045
ParticipantsOG00149
ParticipantsOG00244
ParticipantsOG00348
ParticipantsOG00448
Title
Measurements
OG000162.8(98.7 to 268.5)
OG001224.7(142.3 to 354.7)
OG002124.6(72.0 to 215.5)
OG003
Post Dose 2 (Month 2)
ParticipantsOG00043
ParticipantsOG00148
ParticipantsOG00241
ParticipantsOG00348
Post Dose 3 (Month 3)
ParticipantsOG00035
ParticipantsOG00144
ParticipantsOG00240
ParticipantsOG0030
Pre-Dose 3 (Month 7)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00344
Post Dose 3 (Month 8)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00343
Pre-Dose 4 (Month 14)
ParticipantsOG0000
ParticipantsOG00141
ParticipantsOG00240
ParticipantsOG0030
Post Dose 4 (Month 15)
ParticipantsOG0000
ParticipantsOG00137
ParticipantsOG00237
ParticipantsOG0030
Pre-Dose 4 (Month 20)
ParticipantsOG00037
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00342
Post Dose 4 (Month 21)
ParticipantsOG00033
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00338
Pre-Dose 5 (Month 26)
ParticipantsOG0000
ParticipantsOG00138
ParticipantsOG00234
ParticipantsOG0030
Post Dose 5 (Month 27)
ParticipantsOG0000
ParticipantsOG00130
ParticipantsOG00226
ParticipantsOG0030
Pre-Dose 5 (Month 32)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00337
Post Dose 5 (Month 33)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00332
Pre-Dose 6 (Month 38)
ParticipantsOG0000
ParticipantsOG00134
ParticipantsOG00231
ParticipantsOG0030
Post Dose 6 (Month 39)
ParticipantsOG0000
ParticipantsOG00133
ParticipantsOG00228
ParticipantsOG0030
End of Study (Month 50)
ParticipantsOG00030
ParticipantsOG00134
ParticipantsOG00228
ParticipantsOG00325
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG000298
OG001294
OG002304
OG003311
OG004293
Title
Denominators
Categories
Any SAE
Title
Measurements
OG00073
OG00165
OG00264
OG00384
OG00492
Fatal SAE
Title
Measurements
OG0002
OG0011
OG0020
OG003
Related SAE
Title
Measurements
OG0003
OG0010
OG0020
OG003
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG000298
OG001294
OG002304
OG003311
OG004293
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0020
OG0034
OG0041
OG002
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG000298
OG001294
OG002304
OG003311
OG004293
Title
Denominators
Categories
Cerebral malaria
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
Severe malaria
Title
Measurements
OG00029
OG00122
OG00225
OG003
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG000298
OG001294
OG002304
OG003311
OG004293
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0021
OG0030
OG0040
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG000298
OG001294
OG002304
OG003311
OG004293
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0021
OG0033
OG0043
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG000298
OG001294
OG002304
OG003311
OG004293
Title
Denominators
Categories
Title
Measurements
OG0005
OG0011
OG0020
OG0034
OG0044
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG000298
OG001294
OG002304
OG003311
OG004293
Title
Denominators
Categories
Title
Measurements
OG0004
OG0011
OG0020
OG0034
OG0042
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG000298
OG001294
OG002304
OG003311
OG004293
Title
Denominators
Categories
Post 1st 3 doses
ParticipantsOG000298
ParticipantsOG001294
ParticipantsOG002304
ParticipantsOG003311
ParticipantsOG004293
Title
Measurements
OG000223
OG001221
OG002240
OG003
Post Dose 4
ParticipantsOG000244
ParticipantsOG001256
ParticipantsOG002266
ParticipantsOG003267
Post Dose 5
ParticipantsOG0000
ParticipantsOG001247
ParticipantsOG002251
ParticipantsOG003259
Post Dose 6
ParticipantsOG0000
ParticipantsOG001231
ParticipantsOG002245
ParticipantsOG0030
Fx012-14-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG00046
OG00148
OG00244
OG00345
OG00449
Title
Denominators
Categories
Haemoglobin
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Platelets
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatine
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG00044
OG00147
OG00243
OG00341
OG00448
Title
Denominators
Categories
Haemoglobin
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Platelets
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatine
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG00038
OG00145
OG00242
OG00344
OG00449
Title
Denominators
Categories
Haemoglobin
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Platelets
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatine
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.
Units
Counts
Participants
OG00046
OG00148
OG00244
OG00345
OG00449
Title
Denominators
Categories
Any Erythema, after Dose 3
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00244
ParticipantsOG00345
ParticipantsOG00449
Title
Measurements
OG0000
OG0011
OG0020
OG003
Any Erythema, after Dose 4
ParticipantsOG00041
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Any Erythema, after Dose 5
ParticipantsOG0000
ParticipantsOG00142
ParticipantsOG00239
ParticipantsOG00343
Any Erythema, after Dose 6
ParticipantsOG0000
ParticipantsOG00139
ParticipantsOG00238
ParticipantsOG0030
Any Pain, after Dose 3
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00244
ParticipantsOG00345
Any Pain, after Dose 4
ParticipantsOG00041
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Any Pain, after Dose 5
ParticipantsOG0000
ParticipantsOG00142
ParticipantsOG00239
ParticipantsOG00343
Any Pain, after Dose 6
ParticipantsOG0000
ParticipantsOG00139
ParticipantsOG00238
ParticipantsOG0030
Any Swelling, after Dose 3
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00244
ParticipantsOG00345
Any Swelling, after Dose 4
ParticipantsOG00041
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Any Swelling, after Dose 5
ParticipantsOG0000
ParticipantsOG00142
ParticipantsOG00239
ParticipantsOG00343
Any Swelling, after Dose 6
ParticipantsOG0000
ParticipantsOG00139
ParticipantsOG00238
ParticipantsOG0030
Fx017-mFxD Group
Participants received a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.
OG004
Control Group
Participants received rabies vaccine at Month 0, Month 1 and Month 2.