First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Children
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چکیده
Methods From March 2009 through January 2011, we enrolled 15,460 children in two age categories — 6 to 12 weeks of age and 5 to 17 months of age — for vaccination with either RTS,S/AS01 or a non-malaria comparator vaccine. The primary end point of the analysis was vaccine efficacy against clinical malaria during the 12 months after vaccination in the first 6000 children 5 to 17 months of age at enrollment who received all three doses of vaccine according to protocol. After 250 children had an episode of severe malaria, we evaluated vaccine efficacy against severe malaria in both age categories.
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First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Children
Methods From March 2009 through January 2011, we enrolled 15,460 children in two age categories — 6 to 12 weeks of age and 5 to 17 months of age — for vaccination with either RTS,S/AS01 or a non-malaria comparator vaccine. The primary end point of the analysis was vaccine efficacy against clinical malaria during the 12 months after vaccination in the first 6000 children 5 to 17 months of age at...
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318 www.thelancet.com Vol 387 January 23, 2016 As vaccine manufacturers tackle increasingly intractable pathogens, vaccines will be developed that show effi cacy, but that are less effi cacious than established vaccines. Consequently, regulatory and public health authorities will be faced with diffi cult decisions about whether such vaccines should be recommended for implementation and, if so, ...
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