PMID- 29573143
OWN - NLM
STAT- MEDLINE
DCOM- 20190411
LR  - 20240327
IS  - 1750-2659 (Electronic)
IS  - 1750-2640 (Print)
IS  - 1750-2640 (Linking)
VI  - 12
IP  - 4
DP  - 2018 Jul
TI  - The safety and efficacy of quadrivalent live attenuated influenza vaccine in 
      Japanese children aged 2-18 years: Results of two phase 3 studies.
PG  - 438-445
LID - 10.1111/irv.12555 [doi]
AB  - 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: Quadrivalent live 
      attenuated influenza vaccine 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.
CI  - (c) 2018 The Authors. Influenza and Other Respiratory Viruses Published by John 
      Wiley & Sons Ltd.
FAU - Mallory, Raburn M
AU  - Mallory RM
AUID- ORCID: 0000-0002-2563-9981
AD  - MedImmune, Gaithersburg, MD, USA.
FAU - Yu, Jing
AU  - Yu J
AD  - MedImmune, Gaithersburg, MD, USA.
FAU - Kameo, Sachiko
AU  - Kameo S
AD  - AstraZeneca Japan, Osaka, Japan.
FAU - Tanaka, Michio
AU  - Tanaka M
AD  - AstraZeneca Japan, Osaka, Japan.
FAU - Rito, Ki
AU  - Rito K
AD  - Formerly of AstraZeneca Japan, Tokyo, Japan.
FAU - Itoh, Yohji
AU  - Itoh Y
AD  - AstraZeneca Japan, Osaka, Japan.
FAU - Dubovsky, Filip
AU  - Dubovsky F
AD  - MedImmune, Gaithersburg, MD, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180410
PL  - England
TA  - Influenza Other Respir Viruses
JT  - Influenza and other respiratory viruses
JID - 101304007
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Influenza Vaccines/*adverse effects/*immunology
MH  - Influenza, Human/*prevention & control
MH  - Japan/epidemiology
MH  - Male
PMC - PMC6005581
OTO - NOTNLM
OT  - Japan
OT  - LAIV
OT  - pediatric
OT  - seasonal influenza
EDAT- 2018/03/25 06:00
MHDA- 2019/04/12 06:00
PMCR- 2018/07/01
CRDT- 2018/03/25 06:00
PHST- 2018/02/27 00:00 [accepted]
PHST- 2018/03/25 06:00 [pubmed]
PHST- 2019/04/12 06:00 [medline]
PHST- 2018/03/25 06:00 [entrez]
PHST- 2018/07/01 00:00 [pmc-release]
AID - IRV12555 [pii]
AID - 10.1111/irv.12555 [doi]
PST - ppublish
SO  - Influenza Other Respir Viruses. 2018 Jul;12(4):438-445. doi: 10.1111/irv.12555. 
      Epub 2018 Apr 10.