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The safety and efficacy of quadrivalent live attenuated influenza vaccine in Japanese children aged 2-18 years: results of two phase 3 studies.

The safety and efficacy of quadrivalent live attenuated influenza vaccine in Japanese children aged 2-18 years: results of two phase 3 studies.
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Mallory RM, Yu J, Kameo S, Tanaka M, Rito K, Itoh Y, Dubovsky F,


Mallory RM, Yu J, Kameo S, Tanaka M, Rito K, Itoh Y, Dubovsky F, (click to view)

Mallory RM, Yu J, Kameo S, Tanaka M, Rito K, Itoh Y, Dubovsky F,

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Influenza and other respiratory viruses 2018 03 23() doi 10.1111/irv.12555
Abstract
BACKGROUND
Quadrivalent live attenuated influenza vaccine (Q/LAIV) has not been assessed in Japanese children.

OBJECTIVES
Evaluate safety and efficacy of Q/LAIV in Japanese children.

PATIENTS/METHODS
Two Phase 3 studies were conducted in the 2014-2015 influenza season. Study 1 was an open-label, uncontrolled single arm, multicenter study of Q/LAIV safety in subjects aged 2-6 years. Study 2 was a randomized, double-blind, placebo-controlled multicenter study of Q/LAIV safety and efficacy; subjects aged 7-18 years were randomized 2:1 to receive Q/LAIV or placebo. Primary efficacy endpoint was laboratory-confirmed symptomatic influenza infection caused by vaccine-matched strains; secondary endpoint evaluated efficacy against all strains regardless of match. Both studies reported solicited symptoms, adverse events (AEs) and serious AEs.

RESULTS
In Study 1, 100 subjects received Q/LAIV. In Study 2, 1301 subjects received Q/LAIV (n=868) or placebo (n=433). Treatment-emergent AEs occurred in 42% of subjects in Study 1, and in 24.3% of subjects in the Q/LAIV arm and in 25.9% of subjects in the placebo arm in Study 2. In Study 2, a single infection by a vaccine-matched strain was reported in the placebo arm, resulting in a vaccine efficacy estimate of 100% (95% CI: -1875.3, 100.0); efficacy for all strains regardless of match to the vaccine was 27.5% (95% CI: 7.4, 43.0).

CONCLUSIONS
Q/LAIV did not meet its primary efficacy endpoint as only a single infection by a vaccine-matched strain was detected; however, efficacy for the secondary endpoint, all strains regardless of match, was achieved. Q/LAIV was generally well tolerated in the Japanese pediatric population. This article is protected by copyright. All rights reserved.

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