tetano
Editor, Senior Moderator
Influenza Other Respir Viruses. 2018 Mar 23. doi: 10.1111/irv.12555. [Epub ahead of print]
[h=1]The safety and efficacy of quadrivalent live attenuated influenza vaccine in Japanese children aged 2-18 years: results of two phase 3 studies.[/h] Mallory RM[SUP]1[/SUP], Yu J[SUP]1[/SUP], Kameo S[SUP]2[/SUP], Tanaka M[SUP]2[/SUP], Rito K[SUP]3[/SUP], Itoh Y[SUP]2[/SUP], Dubovsky F[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Quadrivalent live attenuated influenza vaccine (Q/LAIV) has not been assessed in Japanese children.
[h=4]OBJECTIVES:[/h] Evaluate safety and efficacy of Q/LAIV in Japanese children.
[h=4]PATIENTS/METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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).
[h=4]CONCLUSIONS:[/h] 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.
This article is protected by copyright. All rights reserved.
[h=4]KEYWORDS:[/h] LAIV ; Japan; pediatric; seasonal influenza
PMID: 29573143 DOI: 10.1111/irv.12555
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[h=1]The safety and efficacy of quadrivalent live attenuated influenza vaccine in Japanese children aged 2-18 years: results of two phase 3 studies.[/h] Mallory RM[SUP]1[/SUP], Yu J[SUP]1[/SUP], Kameo S[SUP]2[/SUP], Tanaka M[SUP]2[/SUP], Rito K[SUP]3[/SUP], Itoh Y[SUP]2[/SUP], Dubovsky F[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Quadrivalent live attenuated influenza vaccine (Q/LAIV) has not been assessed in Japanese children.
[h=4]OBJECTIVES:[/h] Evaluate safety and efficacy of Q/LAIV in Japanese children.
[h=4]PATIENTS/METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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).
[h=4]CONCLUSIONS:[/h] 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.
This article is protected by copyright. All rights reserved.
[h=4]KEYWORDS:[/h] LAIV ; Japan; pediatric; seasonal influenza
PMID: 29573143 DOI: 10.1111/irv.12555
Free full text