Why the study?
Does an inactivated EV71 vaccine improve immunogenicity and maintain safety in healthy children and infants?
Population
360 healthy Chinese children and infants, stratified into 2 age groups (6-12 and 13-60 months)
Comparison
Inactivated, alum-adjuvanted EV71 vaccine… vs Placebo
Design
RCT, randomly allocated by the ratio of 1:1:1:1, double-blind
Follow-up
56 days
Authors
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Supports two-dose EV71 vaccination in seronegative children; confirms high immunogenicity with safety comparable to placebo in RCT.
Does an inactivated EV71 vaccine improve immunogenicity and maintain safety in healthy children and infants?
The inactivated EV71 vaccine is well tolerated and highly immunogenic in healthy children and infants, requiring two doses for immunologically naive individuals.
Zhu et al. (2012) studied this question.
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