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PICO
Question: Among 6-week- to 17-month-old children, is the RTS malaria vaccine safe and does it protect against malaria?
Question type: Intervention
Study design: Randomized clinical trial
An international group of researchers performed this double-blind, randomized trial involving eleven centers in seven African countries to determine the efficacy, safety, and immunogenicity of RTS,S/AS01, a candidate malaria vaccine in infants and young children. The vaccine is a recombinant vaccine in which the malaria protein is fused to the hepatitis B surface antigen. After enrollment in the study, children were divided into two age groups: 6 to 12 weeks (6,537 participants) and 5 to 17 months (8,923 participants).
Children in each group were then randomly assigned to three doses of the vaccine at one-month intervals; a control group received a non-malaria vaccine. In the 6 to 12 weeks age group, the control vaccine was a meningococcal C conjugate …
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