Key result
Two doses of the Vigoo EV71 vaccine demonstrated 94.84% overall efficacy (95% CI 83.53%-98.38%; P<.0001) against EV71-associated hand-foot-and-mouth disease over a 2-year follow-up period.
Why the study?
Does 2 doses of Vigoo EV71 vaccine prevent EV71-associated hand-foot-and-mouth disease in healthy Chinese children aged 6-35 months?
Population
10,245 healthy Chinese infants and children aged 6-35 months
Comparison
2 doses of Vigoo enterovirus 71 vaccine at days… vs 2 doses of placebo at days 0 and 28
Design
RCT, 1:1 ratio, open-label
Follow-up
2 years
Authors
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Supports routine EV71 vaccination in young children; extends short-term trial data to confirm 2-year durability.
RCT (n=10,245)
Open-label
1:1
Does 2 doses of Vigoo EV71 vaccine prevent EV71-associated hand-foot-and-mouth disease in healthy Chinese children aged 6-35 months?
Effect estimate: Efficacy 94.84% (95% CI 83.53%-98.38%)
p-value: p=<.0001
Two doses of the Vigoo EV71 vaccine provide sustained, high-level protection against EV71-associated hand-foot-and-mouth disease over 2 years in healthy children.
Wei et al. (2016) conducted an RCT in EV71-associated hand-foot-and-mouth disease (HFMD) (n=10,245). Vigoo enterovirus 71 (EV71) vaccine vs. Placebo was evaluated on EV71-associated hand-foot-and-mouth disease (HFMD) (Efficacy 94.84%, 95% CI 83.53%-98.38%, p=<.0001). Two doses of the Vigoo EV71 vaccine demonstrated 94.84% overall efficacy (95% CI 83.53%-98.38%; P<.0001) against EV71-associated hand-foot-and-mouth disease over a 2-year follow-up period.
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