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Enterovirus 71 (EV71) infections in children have manifestations ranging from no symptoms to hand, foot, and mouth disease, herpangina, and potentially fatal meningoencephalitis. Investigators in Taiwan and Vietnam evaluated the safety, immunogenicity, and efficacy of EV71vac — an alum-adjuvanted, inactivated, whole-virus EV71 genotype B4 vaccine approved for use in China — in 3061 children aged 2–71 months. Participants were randomized 1:1 to receive 2 doses of vaccine (3 doses for those younger than 24 months) or adjuvant only. The primary endpoint was vaccine efficacy at preventing virologically confirmed EV71-associated diseases starting 14 days after the second dose.
At 14 months' follow up, 22 cases of virologically confirmed EV71 dise…