Phase 3
N=5,920
Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ)
Malaria,Falciparum · Children, Only
Bottom Line
View on ClinicalTrials.gov: NCT03143218 ↗Enrolled (actual)
5,920
Serious AEs
4.4%
Results posted
Jan 2022
Primary outcome: Primary: Incidence of Clinical Episodes of Malaria — 304.8; 278.2; 113.3 No. of events/1000 person years at risk
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RABIPUR® (Biological); RTS,S/AS01 (Biological); SMC with SP+AQ (Drug); SMC placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- London School of Hygiene and Tropical Medicine
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Clinical Episodes of Malaria |
304.8; 278.2; 113.3 | — |
| SECONDARY Clinical Episodes of Uncomplicated Febrile Illness |
— | — |
| SECONDARY Hospital Admissions With Malaria, Including Severe Malaria |
— | — |
| SECONDARY Prevalence of Malaria Infection Not Severe Enough to Warrant a Clinic Visit |
— | — |
| SECONDARY Prevalence of Malaria Parasitaemia, Including Gametocytaemia and the Prevalence of Moderate and Severe Anemia and Malnutrition |
— | — |
| SECONDARY Serious Adverse Events (SAEs) |
— | — |
| SECONDARY Immune Response to the Vaccine (Anti-CSP Antibody Concentrations) |
— | — |
| SECONDARY Drug Resistance to SP and AQ |
— | — |
| SECONDARY Prevalence of Malaria Parasitaemia in School Aged Children |
— | — |
| SECONDARY SP+AQ Drug Sensitivity |
— | — |
Summary
A double-blind, individual randomised trial will be undertaken in 6000 children under the age of five years living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine whether the malaria vaccine RTS,S/AS01 is (a) as effective as SMC with SP + AQ in preventing clinical malaria (b) provides additional, useful protection when given together with SMC. The primary trial end-point will be the incidence of clinical episodes of malaria detected by passive case detection.
Eligibility Criteria
Inclusion Criteria
- The child is a permanent resident of the study area and likely to remain a resident for the duration of the trial
- The child is 5 - 17 months of age at the time of first vaccination
- A parent or legally recognised guardian provides informed consent for the child to join the trial
Exclusion Criteria
- The child is a transient resident in the study area
- The child is in care
- The age of the child is outside the stipulated range
- The child has a history of an adverse reaction to SP or AQ
- The child has a serious underlying illness, including known HIV infection, unless this is well controlled by treatment, or severe malnutrition (weight for age or mid arm circumference Z scores < 3 SD)
- The child is known to have an immune deficiency disease or is receiving an immunosuppressive drug
- The child has previously received a malaria vaccine.
- The child is enrolled in another malaria intervention trial
- The parents or guardians do not provide informed consent
Data sourced from ClinicalTrials.gov (NCT03143218). 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.