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PICO
Question: Among children ages 3 to 8 years, what is the efficacy of the new quadrivalent inactivated influenza vaccine in preventing mild and moderate-to-severe influenza?
Question type: Intervention
Study design: Randomized controlled
Investigators from 15 centers in 8 countries sought to evaluate the efficacy of a candidate quadrivalent inactivated influenza vaccine (QIV) containing the A/H1N1, A/H3N2, B/Victoria, and B/Yamagata strains. Healthy children 3 to 8 years of age were randomly assigned, in a 1:1 ratio, to receive QIV (1 or 2 doses depending on their vaccine priming status) or hepatitis A vaccine as a control. Both vaccines were manufactured by GlaxoSmithKline Biologicals, the sponsor of this clinical trial.
Enrollment began in December 2010. Active and passive surveillance for influenza-like illness (ILI) – defined as a temperature …
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