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Enterovirus 71 (EV71) is associated with hand, foot, and mouth disease (HFMD) and other, more-serious conditions. Infants and young children are most affected; epidemics have been especially severe in Asia (JW Infect Dis Jan 30 2013).
Investigators (with partial manufacturer support) recently conducted a multicenter, double-blind, phase III trial of an inactivated alum-adjuvanted EV71 vaccine based on genotype C4, the predominant strain in mainland China. Healthy children in that country, aged 6 to 35 months, were randomized to receive vaccine or placebo (alum adjuvant), administered on days 0 and 28. Of 10,245 enrollees, 96% received both doses.
During active surveillance (from day 56 to month 14), vaccine efficacy in the per-protocol popula…