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QUESTION: Is an intranasal, trivalent, live, attenuated influenza virus (LAIV) vaccine effective and safe for reducing febrile illness in healthy, working adults?
Randomised (allocation not concealed*), blinded (participants and study personnel),* placebo controlled trial with follow up during site specific 7 week peak outbreak periods.
13 sites in the continental United States.
4561 people (mean age 38 y, 55% women) who were 18 to 64 years of age, worked ≥30 h/wk outside of the home, and had health insurance. Exclusion criteria included hypersensitivity to eggs, indication for or previous receipt of the inactivated vaccine, and pregnancy or unprotected risk for pregnancy in the previous 3 months. Follow up was 93%.
From September 18 to November 15, 1997, 3041 participants received the LAIV vaccine …
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