CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,920 enrolled
Drug / intervention
RABIPUR® +3 morebiological
Likely dose
RTS,S/AS01: three doses (April, May, June Year 1) then one booster dose (June Years 2-3); SMC with SP+AQ: sulphadoxine-pyrimethamine 500mg/25mg and amodiaquine 150mg on day 1, then amodiaquine 150mg on days 2-3, four cycles per transmission seasonAI-extracted
Key inclusion· 3
  • ✓Child aged 5-17 months at first vaccination
  • ✓Permanent resident of study area likely to remain for trial duration
  • ✓Parent or legally recognized guardian provides informed consent
Key exclusion· 6
  • ✕Prior malaria vaccine receipt
  • ✕History of adverse reaction to SP or AQ
  • ✕Serious underlying illness including uncontrolled HIV, or severe malnutrition (Z-score <-3 SD)
  • ✕Known immune deficiency disease or immunosuppressive drug use

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03143218
NCT03143218Phase 3Completed
CompareCT.gov

A Phase IIIB Comparative Trial of Seasonal Vaccination With the Malaria Vaccine RTS,S/AS01, Seasonal Malaria Chemoprevention and of the Two Interventions Combined

London School of Hygiene and Tropical Medicine·interventional·Posted May 8, 2017·Updated Apr 7, 2022

In Brief

A Phase 3 clinical trial evaluating RABIPUR®, RTS,S/AS01, and 2 other interventions for Malaria,Falciparum and Children, Only. Completed, enrolled 5,920 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria,Falciparum, Children, Only
CountriesBurkina Faso, Mali
CollaboratorsMalaria Research and Training Center, Bamako, Mali, Institut de Recherche en Sciences de la Sante, Burkina Faso

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 8, 2017
Enrollment StartApr 17, 2017
Primary CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.2 years ago

Interventions

RABIPUR®biological

Year 1 (2017) Three doses of rabies vaccine (April, May, June) Year 2 and 3 (2018/19) One dose of Hepatitis A vaccine (June)

RTS,S/AS01biological

Year 1 (2017) Three doses of RTSS/AS01 (April, May, June) Year 2 and 3 (2018/19) One booster dose of RTSS/AS01 (June)

SMC with SP+AQdrug

Year 1, 2 and 3(2017/18/19) Four cycles of SMC (SP+AQ) during the malaria transmission season One cycle of SMC for children above one year of age consisting of sulphadoxine - pyrimethamin (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3. Infants will receive half of these doses.

SMC placebodrug

Year 1, 2 and 3(2017/18/19) Four cycles of SMC placebo during the malaria transmission season