A study assessing the safety, efficacy, and impact of GlaxoSmithKline Biologicals' RTS, S/AS01E malaria vaccine in young children across sub-Saharan AfricaEPI-MAL-003
Trial overview
Number of participants with adverse events of special interest (AESI) among children vaccinated with RTS,S/AS01E
Timeframe: From Day 0 (vaccination) up to the end of the protocol-defined AESI at-risk period
Number of participants with aetiology-confirmed meningitis among children vaccinated with RTS,S/AS01E
Timeframe: From Day 0 up to Month 12 (end of aetiology-confirmed meningitis at-risk period)
Active Surveillance: Incident rate of aetiology-confirmed meningitis among children vaccinated or unvaccinated with RTS,S/AS01E
Timeframe: From Day 0 up to Month 12 (end of aetiology-confirmed meningitis at-risk period)
EHS: Number of participants with aetiology-confirmed meningitis among children vaccinated or unvaccinated with RTS,S/AS01E
Timeframe: From Day 0 up to Month 12 (end of aetiology-confirmed meningitis at-risk period)
Active Surveillance: Incident rate of probable meningitis
Timeframe: From Day 0 up to Month 12 (end of probable meningitis at-risk period)
EHS: Number of participants with probable meningitis
Timeframe: From Day 0 up to Month 12 (end of probable meningitis at-risk period)
Active surveillance: Incident rate of clinically suspected meningitis
Timeframe: From Day 0 up to Month 12 (end of clinically suspected meningitis at risk period)
EHS: Number of participants with clinically suspected meningitis
Timeframe: From Day 0 up to Month 12 (end of clinically suspected meningitis at risk period)
Active surveillance: Incident rate of cerebral malaria
Timeframe: From Day 0 up to Month 12 (end of cerebral malaria at-risk period)
EHS: Number of participants with cerebral malaria
Timeframe: From Day 0 up to Month 12 (end of cerebral malaria at-risk period)
Active Surveillance: Incident rate of deaths (all-cause)
Timeframe: From Day 0 up to Month 44 (Study End)
EHS: Number of participants with deaths (all-cause)
Timeframe: From Day 0 up to Month 44 (Study End)
Active surveillance: Incident rate of deaths related to AESIs, AEs, meningitis and malaria
Timeframe: From Day 0 up to Month 44 (Study End)
EHS: Number of participants with deaths related to AESIs, AEs, meningitis and malaria
Timeframe: From Day 0 up to Month 44 (Study End)
Number of episodes of any malaria, severe malaria, and cerebral malaria diagnosed by rapid diagnostic test (RDT) and/or microscopy
Timeframe: From Day 0 up to Month 44 (Study End)
Active Surveillance: Number of participants hospitalized with anemia
Timeframe: From Day 0 up to Month 44 (Study End)
Active Surveillance: Number of hospitalization cases (for malaria and P. falciparum)
Timeframe: From Day 0 up to Month 44 (Study End)
Incident rate of any malaria, severe malaria and cerebral malaria, and estimation of direct effect of vaccination on the incidence of malaria
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of any malaria, severe malaria and cerebral malaria, and estimation of overall effect of vaccination on the incidence of malaria
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of any malaria, severe malaria and cerebral malaria, and estimation of total effect of vaccination on the incidence of malaria
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of any malaria, severe malaria and cerebral malaria, and estimation of indirect effect of vaccination on the incidence of malaria
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of any anemia and severe anemia among hospitalised children, and estimation of direct effect of vaccination on the incidence of anemia
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of any anemia and severe anemia among hospitalised children, and estimation of overall effect of vaccination on the incidence of anemia
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of any anemia and severe anemia among hospitalised children, and estimation of total effect of vaccination on the incidence of anemia
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of any anemia and severe anemia among hospitalised children, and estimation of indirect effect of vaccination on the incidence of anemia
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of hospitalisations attributed to malaria and estimation of direct effect of vaccination on the incidence of hospitalisations
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of hospitalisations attributed to malaria and estimation of overall effect of vaccination on the incidence of hospitalisations
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of hospitalisations attributed to malaria and estimation of total effect of vaccination on the incidence of hospitalisations
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of hospitalisations attributed to malaria and estimation of indirect effect of vaccination on the incidence of hospitalisations
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of deaths (all-cause mortality and deaths attributed to malaria) and estimation of direct effect of vaccination on the incidence of deaths
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of deaths (all-cause mortality and deaths attributed to malaria) and estimation of overall effect of vaccination on the incidence of deaths
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of deaths (all-cause mortality and deaths attributed to malaria) and estimation of total effect of vaccination on the incidence of deaths
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Incident rate of deaths (all-cause mortality and deaths attributed to malaria) and estimation of indirect effect of vaccination on the incidence of deaths
Timeframe: One year after Dose 4 of RTS,S/AS01E, evaluated from Dose 3, in children who received Dose 3 before 12 months of age and Dose 4 before 30 months of age
Participation criteria
- Inclusion Criteria
- The study participant’s parent(s)/legally acceptable representative(s) (LARs) were, in the opinion of the investigator, able and willing to comply with the requirements of the protocol.
- Inclusion Criteria
- The study participant’s parent(s)/legally acceptable representative(s) (LARs) were, in the opinion of the investigator, able and willing to comply with the requirements of the protocol.
- Written informed consent was provided by either the parent(s) or LAR of the study participant.
- The study participant lived in the Health and Demographic Surveillance System (HDSS) area or an equivalent surveillance system area.
- For enrollment in active surveillance: children were aged <18 months, had received at least one dose of DTP/HepB/Hib vaccine, and were identified either during DTP/HepB/Hib vaccination visits, at hospitalization before the third dose of DTP/HepB/Hib vaccine, or at the time of the first RTS,S/AS01E dose administration. This group included children from both exposed and unexposed clusters. OR
- For enrollment in enhanced hospitalization surveillance: children were aged >=6 weeks and <5 years at the time of hospitalization at any point during the study. This group included children from both exposed and unexposed clusters. Exclusion Criteria
- Children in care were excluded. A child in care was defined as a child who had been placed under the control or protection of an agency, organization, institution, or entity by the courts, government, or a government body, acting in accordance with powers conferred by law or regulation. This definition included children cared for by foster parents or living in a care home or institution when the arrangement met the above definition. It did not include children who were adopted or had an appointed legal guardian.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.