Last Updated

18 Sep 2020

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

Objectives

The overall goal of this project is to determine whether (a) the addition of seasonal vaccination with RTS,S to SMC is superior to either intervention given alone in reducing the incidence of clinical episodes of malaria in young children and (b) whether RTS,S alone is inferior to SMC alone.

Principal Investigator
Funding Information
Joint Global Health Trials Scheme
Rationale and Abstract

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. The costs of each intervention and its delivery will be determined and compared.

ClinicalTrials.gov Identifier: NCT03143218

Study Design
Study Type  : Interventional  (Clinical Trial)
Actual Enrollment  : 5920 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A double-blind, individually randomised trial to compare the incidence of clinical episodes of malaria across three study arms:

  1. Seasonal vaccination with the malaria vaccine RTS,S/AS01
  2. Seasonal malaria chemoprevention with SP/AQ
  3. Combination of these two interventions
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention