Last updated: 06/17/2025 08:00:37
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A prospective study to estimate the incidence of diseases specified as adverse events of special interest, of other adverse events leading to hospitalisation or death, and of meningitis in infants and young children in sub-Saharan Africa prior to implementation of the RTS,S/AS01E candidate vaccine
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with at least one adverse events of specific interest (AESI) from Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)
Number of participants with at least one adverse event (AE) leading to hospitalization or death from Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)
Number of participants with at least one aetiology confirmed meningitis from Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)
Secondary outcomes:
Number of participants with at least one confirmed meningitis case from Month 0 to Month 79 (final classification)
Timeframe: During the entire study period (From Month 0 up to Month 79)
Number of participants with at least one confirmed meningitis case identified at site level from Month 0 to Month 79 (first line laboratory)
Timeframe: During the entire study period (From Month 0 up to Month 79)
Number of participants with risk factors for AESI, meningitis and malaria among hospitalized participants
Timeframe: During the entire study period (From Month 0 up to Month 79)
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
Timeframe: Day 31 to approximately Month 13 (Within an at-risk period of 12 months after virtual secondary schedule)
Number of participants hospitalized with causes (including those attributed to an AESI, other AE, meningitis, or malaria) from Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)
Number of participants reported deaths from Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)
Number of participants with malaria cases reported using rapid diagnostic test (RDT) and/or microscopy from Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)
Number of participants with all anaemia and severe anaemia cases among hospitalized children from Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)
Number of participants with all cause hospitalizations and hospitalizations attributed to malaria (including P. falciparum) from Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)
Number of participants reported all-cause mortality and deaths attributed to malaria (overall and by gender) from Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)
Interventions:
Enrollment:
36366
Primary completion date:
2022-02-08
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Asante K, Bozonnat M, Savic M, OWUSU-AGYEI S, Kaali S, Otieno W, et al. . Incidence rates of malaria, meningitis, and mortality in children younger than 5 years: a prospective cohort study in Ghana and Kenya before the roll-out of the RTS,S/AS01E malaria vaccine from 2016 to 2022. Lancet Glob Health. 2025;19: e859-869. doi:10.1016/S2214-109X(25)00022-1 https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(25)00022-1/fulltext
PMID: 40288396
DOI: 10.1016/S2214-109X(25)00022-1
Medical condition
Malaria
Product
SB257049
Collaborators
PATH (Program for Appropriate Technology in Health), AMP (Agence de Médecine Préventive) (in French), RAFT (Réseau en Afrique Francophone pour la Télémédecine) (in French), IQVIA, Parexel (Mobile Phone Alert System Provider), CLS (Clinical Laboratory Services)
Study date(s)
October 2015 to August 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable - 5 Years
Accepts healthy volunteers
Yes
- 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.
- Child in care.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
All subjects must satisfy ALL the following criteria at study entry:
Exclusion criteria:
Child in care.
Trial location(s)
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2022-02-08
Actual study completion date
2022-02-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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