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A phase III randomized trial of RTS,S/AS01 candidate malaria vaccine was initiated in 2009 at 11 centers in 7 sub-Saharan countries (NEJM JW Infect Dis Dec 2011 and N Engl J Med 2011; 365:1863). Investigators now report the final results of this partially industry-supported trial (median follow-up after dose 1, 48 months for children and 38 months for infants). One group received a booster dose 20 months after the first of three initial doses.
With a booster, efficacy against clinical malaria until study end was 36.3% in children and 25.9% in infants; without a booster, it was 28.3% and 18.3%, respectively. Efficacy waned over time and was not detectable by trial end in those without a booster. Children who did not receive a booster were at …