Time to Change Dosing of Inactivated Quadrivalent Influenza Vaccine in Young Children: Evidence From a Phase III, Randomized, Controlled Trial

Overview

Journal J Pediatric Infect Dis Soc

Publisher Oxford University Press

Specialties Infectious Diseases
Pediatrics

Date 2017 Jan 8

PMID 28062552

Citations 12

Authors

Varsha K Jain

Joseph B Domachowske

Long Wang

Opokua Ofori-Anyinam

Miguel A Rodriguez-Weber

Michael L Leonardi

Nicola P Klein

Gary Schlichter

Robert Jeanfreau

Byron L Haney

Laurence Chu

Jo-Ann S Harris

Kwabena O Sarpong

Amanda C Micucio

Jyoti Soni

Vijayalakshmi Chandrasekaran

Ping Li

Bruce L Innis

Affiliations

Soon will be listed here.

Abstract

Background.: Children under 3 years of age may benefit from a double-dose of inactivated quadrivalent influenza vaccine (IIV4) instead of the standard-dose.

Methods.: We compared the only United States-licensed standard-dose IIV4 (0.25 mL, 7.5 µg hemagglutinin per influenza strain) versus double-dose IIV4 manufactured by a different process (0.5 mL, 15 µg per strain) in a phase III, randomized, observer-blind trial in children 6-35 months of age (NCT02242643). The primary objective was to demonstrate immunogenic noninferiority of the double-dose for all vaccine strains 28 days after last vaccination. Immunogenic superiority of the double-dose was evaluated post hoc. Immunogenicity was assessed in the per-protocol cohort (N = 2041), and safety was assessed in the intent-to-treat cohort (N = 2424).

Results.: Immunogenic noninferiority of double-dose versus standard-dose IIV4 was demonstrated in terms of geometric mean titer (GMT) ratio and seroconversion rate difference. Superior immunogenicity against both vaccine B strains was observed with double-dose IIV4 in children 6-17 months of age (GMT ratio = 1.89, 95% confidence interval [CI] = 1.64-2.17, B/Yamagata; GMT ratio = 2.13, 95% CI = 1.82-2.50, B/Victoria) and in unprimed children of any age (GMT ratio = 1.85, 95% CI = 1.59-2.13, B/Yamagata; GMT ratio = 2.04, 95% CI = 1.79-2.33, B/Victoria). Safety and reactogenicity, including fever, were similar despite the higher antigen content and volume of the double-dose IIV4. There were no attributable serious adverse events.

Conclusions.: Double-dose IIV4 may improve protection against influenza B in some young children and simplifies annual influenza vaccination by allowing the same vaccine dose to be used for all eligible children and adults.

Citing Articles

Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6-35 months of age in China: A randomized, double-blind, clinical trial.

Wang S, Wang Y, Chen D, Xu W, Duan P, Ji W Hum Vaccin Immunother. 2024; 20(1):2425149.

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Summary of the National Advisory Committee on Immunization (NACI) Statement-Recommendations on Fractional Influenza Vaccine Dosing in the Event of a Shortage: Pandemic preparedness.

Sinilaite A, Doyon-Plourde P, Young K, Harrison R Can Commun Dis Rep. 2024; 49(4):90-98.

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Lunny C, Antony J, Rios P, Williams C, Ramkissoon N, Straus S BMJ Open. 2021; 11(9):e050596.

PMID: 34535483 PMC: 8450963. DOI: 10.1136/bmjopen-2021-050596.

Indian Academy of Pediatrics (IAP) Advisory Committee on Vaccines and Immunization Practices (ACVIP): Recommended Immunization Schedule (2020-21) and Update on Immunization for Children Aged 0 Through 18 Years.

Kasi S, Shivananda S, Marathe S, Chatterjee K, Agarwalla S, Kant Dhir S Indian Pediatr. 2020; 58(1):44-53.

PMID: 33257602 PMC: 7840391.

Evaluation of Waning Immunity at 6 Months after Both Trivalent and Quadrivalent Influenza Vaccination in Korean Children Aged 6-35 Months.

Lee J, Cho H, Kim K, Lee J, Kim Y, Eun B J Korean Med Sci. 2019; 34(46):e279.

PMID: 31779056 PMC: 6882944. DOI: 10.3346/jkms.2019.34.e279.

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