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

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

SUBMITTER: Mallory RM 

PROVIDER: S-EPMC6005581 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature