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

Autor:	Ki Rito, Michio Tanaka, Yohji Itoh, Sachiko Kameo, Filip Dubovsky, Raburn M. Mallory, Jing Yu
Rok vydání:	2018
Předmět:	Male 0301 basic medicine Pulmonary and Respiratory Medicine medicine.medical_specialty Adolescent Epidemiology 030106 microbiology Influenza season Placebo 03 medical and health sciences Single infection 0302 clinical medicine Japan Double-Blind Method Internal medicine Influenza Human Humans Medicine Live attenuated influenza vaccine 030212 general & internal medicine Child Adverse effect LAIV business.industry Public Health Environmental and Occupational Health Original Articles Vaccine efficacy pediatric Infectious Diseases Multicenter study Influenza Vaccines Child Preschool Original Article seasonal influenza Female business Pediatric population
Zdroj:	Influenza and Other Respiratory Viruses
ISSN:	1750-2640
DOI:	10.1111/irv.12555
Popis:	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.
Databáze:	OpenAIRE
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