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An Optimized Hemagglutination Inhibition HI Assay to Quantify Influenza-specific Antibody Titers
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Published on: December 1, 2017

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

Varsha K Jain1, Joseph B Domachowske2, Long Wang1

  • 1GSK Vaccines, King of Prussia, Pennsylvania.

Journal of the Pediatric Infectious Diseases Society
|January 8, 2017
PubMed

Insights

A double-dose of inactivated quadrivalent influenza vaccine (IIV4) demonstrated noninferior immunogenicity compared to the standard dose in children 6-35 months. This enhanced IIV4 dose may improve protection against influenza B in young children.

Area of Science:

  • Pediatric Vaccinology
  • Immunology
  • Infectious Disease Prevention

Background:

  • Young children (under 3 years) may benefit from a higher antigen dose of inactivated quadrivalent influenza vaccine (IIV4).
  • Standard IIV4 dose is 0.25 mL (7.5 µg HA/strain), while a double-dose is 0.5 mL (15 µg HA/strain).

Purpose of the Study:

  • To demonstrate immunogenic noninferiority of a double-dose IIV4 compared to a standard-dose IIV4 in children aged 6-35 months.
  • To evaluate the safety and reactogenicity of the double-dose IIV4.
  • To assess potential superior immunogenicity of the double-dose IIV4 post hoc.

Main Methods:

  • Phase III, randomized, observer-blind trial involving 2424 children aged 6-35 months.
  • Immunogenicity assessed via geometric mean titers (GMT) and seroconversion rates in 2041 participants (per-protocol cohort).
  • Safety and reactogenicity evaluated in the intent-to-treat cohort.

Main Results:

  • Immunogenic noninferiority of double-dose IIV4 was confirmed for all strains.
  • Superior immunogenicity against both influenza B strains was observed with double-dose IIV4 in children 6-17 months and unprimed children.
  • Similar safety and reactogenicity profiles, including fever, were noted between the standard and double doses, with no attributable serious adverse events.

Conclusions:

  • Double-dose IIV4 offers potential for improved protection against influenza B in specific pediatric populations.
  • This dosing strategy simplifies annual influenza vaccination by enabling a single dose for all eligible individuals, from children to adults.
Abstract

Keywords:
childrendouble-doseinactivated quadrivalent influenza vaccine.

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