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, 2016/17 season.

Abstract

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. Clinical Trial Registry Number: NCT02964065.

• Authors: Shenyu Wang, Yihong Zheng, Xiongyuan Jin, Zhengkai Gan, Yanzhi Shao, Changlin Zhu, Xiaosong Hu, Zhenzhen Liang, Yingping Chen, Bo Xing, Huakun Lv, Na Xu
• Journal: Vaccine (Vaccine) Vol. 38 Issue 38 Pg. 5979-5986 (08 27 2020) ISSN: 1873-2518 [Electronic] Netherlands
• PMID: 32747213 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Influenza Vaccines
• Vaccines, Attenuated

Topics

• Adolescent
• Child
• Child, Preschool
• China (epidemiology)
• Double-Blind Method
• Humans
• Influenza A Virus, H3N2 Subtype
• Influenza Vaccines (adverse effects)
• Influenza, Human (prevention & control)
• Seasons
• Vaccines, Attenuated (adverse effects)