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Last Updated: 19/12/2024

Large-scale implementation of the RTS,S malaria vaccine: phase IV trial

Objectives

The objectives of this trial are to assess the feasibility of administering the required four doses of the RTS,S vaccine in children; the vaccine’s potential role in reducing childhood deaths; and is safety in the context of routine use.

The data and information derived from the trial will inform a WHO policy recommendation on the broader use of the vaccine. 

Rationale and Abstract

RTS,S is the first and, to date, the only vaccine to show a protective effect against malaria among young children in Phase 3 clinical trials.

Beginning in 2018, it will be the first malaria vaccine provided to young children through routine immunization programs. Three sub-Saharan African countries will introduce the vaccine in selected areas as part of a large-scale pilot implementation program.

In each country, the ministry of health will deliver the malaria vaccine through its national immunization program in the selected areas and regions. 

Study Design

Phase IV multi-country trial

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