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Asia accounts for 70% of the global burden of dengue fever. In a multicenter, phase III efficacy trial in five dengue-endemic Asian countries, investigators assessed the efficacy of a recombinant, live, attenuated, tetravalent dengue vaccine against symptomatic, virologically confirmed dengue 1 to 13 months after vaccination completion. The vaccine maker funded the trial.
More than 10,000 healthy children (age range, 2–14 years) were randomly assigned, in a 2:1 ratio, to receive three injections of vaccine or placebo (saline) at 0, 6, and 12 months after enrollment. Participants with fever were tested for dengue nonstructural protein 1 (NS-1) antigen, for dengue on polymerase chain reaction (PCR) testing, for serotype-specific dengue on PCR,…