N/A
N=23,427
A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Children in Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT02374450 ↗Enrolled (actual)
23,427
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants With at Least One Adverse Events of Specific Interest (AESI) From Month 0 to Month 79 — 12; 11; 16 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Blood collection (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One Adverse Events of Specific Interest (AESI) From Month 0 to Month 79 |
12; 11; 16 | — |
| PRIMARY Number of Participants With at Least One Adverse Event (AE) Leading to Hospitalization or Death From Month 0 to Month 79 |
1703; 1763; 4465 | — |
| PRIMARY Number of Participants With at Least One Aetiology Confirmed Meningitis From Month 0 to Month 79 |
1; 1; 11 | — |
| SECONDARY Number of Participants With at Least One Confirmed Meningitis Case From Month 0 to Month 79 (Final Classification) |
2; 2; 15; 1; 1; 4 | — |
| SECONDARY Number of Participants With at Least One Confirmed Meningitis Case Identified at Site Level From Month 0 to Month 79 (First Line Laboratory) |
0; 1; 3; 5; 5; 23 | — |
| SECONDARY Number of Participants With Risk Factors for AESI, Meningitis and Malaria Among Hospitalized Participants |
NA; NA; NA | — |
| SECONDARY Incidence Rates of Death After the Virtual Secondary Schedule (Secondary Dose of DTP/HepB/Hib Administered at Day 31) for the Active Surveillance 6-12 Weeks and Active Surveillance 5-17 Weeks Groups |
677.42; 642.97 | — |
| SECONDARY Number of Participants Hospitalized With Causes (Including Those Attributed to an AESI, Other AE, Meningitis, or Malaria) From Month 0 to Month 79 |
12; 11; 16; 1703; 1763; 4465 | — |
| SECONDARY Number of Participants Reported Deaths From Month 0 to Month 79 |
173; 183; 80 | — |
| SECONDARY Number of Participants With Malaria Cases Reported Using Rapid Diagnostic Test (RDT) and/or Microscopy From Month 0 to Month 79 |
5072; 5714; 2458; 202; 247; 550 | — |
| SECONDARY Number of Participants With All Anaemia and Severe Anaemia Cases Among Hospitalized Children From Month 0 to Month 79 |
1132; 1215; 2783; 254; 338; 758 | — |
| SECONDARY Number of Participants With All Cause Hospitalizations and Hospitalizations Attributed to Malaria (Including P. Falciparum) From Month 0 to Month 79 |
1788; 1907; 4701; 1007; 1218; 2441 | — |
| SECONDARY Number of Participants Reported All-cause Mortality and Deaths Attributed to Malaria (Overall and by Gender) From Month 0 to Month 79 |
81; 105; 49; 92; 78; 31 | — |
Summary
The purpose of this pre-licensure cohort study was to estimate the incidence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis and malaria in sub-Saharan African children under 5 years of age. The outcomes of this study provide the baseline data for the post-licensure EPI-MALARIA-003 (115056) study that evaluated the safety, effectiveness and impact of the RTS,S/AS01E vaccine.
An interim analysis was performed on a sub-group of study participants enrolled in active surveillance from sites where the vaccine was implemented, having 6 months of follow-up after the administration of dose 3 of DTP/HepB/Hib vaccine (6-12 weeks group), or 6 months after Visit 3 (mimicking the RTS,S/AS01E primary vaccination schedule) for the 5-17 months group; corresponding to Visit 5. The interim analysis concerned primary safety endpoints and the main secondary endpoints.
Eligibility Criteria
Inclusion Criteria
All subjects must satisfy ALL the following criteria at study entry:
- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent provided from either the parent(s) or LAR of the subject.
- Subject living in the Health and Demographic Surveillance System (HDSS) area.
- For enrolment in active surveillance: children must be <18 months of age. OR
- For enrolment in enhanced hospitalisation surveillance: children must be <5 years of age and hospitalised at any time during the study.
Exclusion Criteria
- Child in care.
Data sourced from ClinicalTrials.gov (NCT02374450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.