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2020-9-23 21:27:25

Wang S, Zheng Y, Jin X, et al. Efficacy and safety of a live attenuated influenza vaccine in Chinese healthy children aged 3-17 years in one study center of a randomized, double-blind, placebo-controlled phase 3 clinical trial, 201. Vaccine. 2020;S0264-410X(20)30932-4
submited by kickingbird at Aug, 5, 2020 12:2 PM from Vaccine. 2020;S0264-410X(20)30932-4

Background: No data on the safety and efficacy of a live attenuated influenza vaccine in China have ever been reported.
Methods: At a site of a phase 3 randomized, double-blind, placebo-controlled clinical trial in eastern China, eligible healthy children aged 3-17 years underwent randomization to receive live attenuated vaccine or placebo at a ratio of 1:1. The primary objective of the study was the prevention of laboratory-confirmed influenza illness during the surveillance period, starting on day 15 after vaccination.
Results: A total of 2000 participants were enrolled, with 998 receiving the vaccine and 1001 receiving placebo. Sixty-four cases of influenza-like illness were observed, of which, 44 were laboratory-confirmed (12 in vaccine group versus 32 in placebo group). Vaccine efficacy was 62.5% (95%CI: 27.6-80.6) against all types of influenza and 63.3% (95%CI: 27.5-81.5) against influenza H3N2 illness. 11 severe adverse events reported (7 in LAIV group versus 4 in placebo group) were all deemed to be non-vaccine-related. Adverse events occurred in 412 (41.3%) participants in the vaccine group versus 389 (38.9%; p = 0.274) participants in the placebo group. Significant increase incidence of fever was observed in participants in the vaccine group, especially in those aged 3-9 years.
Conclusions: The live attenuated influenza vaccine showed good efficacy and safety among 3- to 17-year-olds children during the 2016-2017 season at a site in eastern China.

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