S Clinical Trials Partnership: A Phase 3 Trial of RTS.

Methods Study Design Details of the study methods have already been described previously3-7 and so are provided in the Supplementary Appendix and the study protocol, both of which are available with the full text of the article at NEJM.org. This phase 3, randomized, managed, double-blind trial has been executed at 11 centers in 7 African countries with a range of malaria-transmission strength . The trial is made to evaluate vaccine efficacy, safety, and immunogenicity for 32 months after the first dosage of study vaccine in children 6 to 12 weeks of age or 5 to 17 months old at enrollment. The trial includes three study groups in each age group category: infants who received three dosages of RTS,S/AS01 administered at 1-month intervals and a booster dose 18 months following the third dosage, infants who received three dosages of RTS,S/AS01 at 1-month intervals without a booster dosage, and a control group of infants who received a non-malaria comparator vaccine. Continue reading