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Outbreaks of enterovirus 71 (EV71) are increasing and pose a large socioeconomic burden, especially in the western Pacific region. An inactivated EV71 vaccine based on subgenotype 4, developed in China, has shown promise in recent studies. Now, researchers (with partial manufacturer support) have conducted a randomized, double-blind, phase II trial to identify the best dose and formulation of this vaccine, based on immunogenicity and safety.
At a single site in China, 1200 infants (aged 6–11 months) and children (aged 12–36 months) received two doses, on days 0 and 28, of one of four vaccine formulations (160 U, 320 U, or 640 U of EV71 antigen with alum adjuvant; or 640 U without adjuvant) or placebo (adjuvant only). Blood samples were obtai…