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PICO
Question: Among healthy children 6 to 71 months old, what is the efficacy of an inactivated enterovirus 71 (EV71) vaccine in preventing EV71-associated hand, foot, and mouth disease?
Question type: Intervention
Study design: Randomized controlled trial
Investigators from multiple institutions in China conducted a randomized controlled trial to evaluate the safety and efficacy of an inactivated enterovirus 71 (EV71) vaccine. Healthy children 6 to 71 months of age were randomly assigned to receive EV71 vaccine or placebo. Two doses of vaccine or placebo were administered intramuscularly, with a 4-week interval between doses. The primary efficacy end point was protection against hand, foot, and mouth disease (HFMD) caused by EV71. Cases of EV71-associated HFMD were defined as clinically diagnosed HFMD in which EV71 was subsequently detected by reverse transcription polymerase chain reaction from …
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