Format

Send to

Choose Destination
J Pediatric Infect Dis Soc. 2017 Mar 1;6(1):9-19. doi: 10.1093/jpids/piw068.

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

Author information

1
GSK Vaccines, King of Prussia, Pennsylvania.
2
SUNY Upstate Medical University, Syracuse, New York.
3
GSK Vaccines, Wavre, Belgium.
4
Instituto Nacional de Pediatría de México, Mexico City.
5
Palmetto Pediatrics, Charleston, South Carolina.
6
Kaiser Permanente Vaccine Study Center, Oakland, California.
7
Jean Brown Research, Salt Lake City, Utah.
8
MedPharmics, Metairie, Louisiana.
9
Family Health Care of Ellensburg, Ellensburg and Pacific Northwest University, Yakima, Washington.
10
Benchmark Research, Austin, Texas.
11
Stormont Vail Health, Topeka, Kansas.
12
Sealy Center for Vaccine Development University of Texas Medical Branch, Galveston.
13
Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.
14
GlaxoSmithKline Pharmaceuticals Ltd, Bangalore, India.

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.

KEYWORDS:

children; double-dose; inactivated quadrivalent influenza vaccine.

PMID:
28062552
PMCID:
PMC5907868
DOI:
10.1093/jpids/piw068
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Silverchair Information Systems Icon for PubMed Central
Loading ...
Support Center