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Pediatr Infect Dis J. 2019 Feb;38(2):203-210. doi: 10.1097/INF.0000000000002217.

Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naïve Children.

Author information

1
From the GSK, Wavre, Belgium.
2
GSK, King of Prussia, Pennsylvania.
3
Hospital Materno-Infantil La Paz, Madrid, Spain.
4
Faculty of Medicine, University Hospital and Charles University, Hradec Králové, Czech Republic.
5
Vaccine Research Department, FISABIO-Public Health, Valencia, Spain.
6
Infectious Diseases Outpatient Clinic, Debica, Poland.
7
Institut Pediàtric Marès-Riera, Girona, Spain.
8
Translational Pediatrics and Infectious Diseases, Department of Pediatrics, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Galicia, Spain.
9
Grupo de Investigación en Genética, Vacunas, Infecciones y Pediatría (GENVIP), Instituto de Investigación Sanitaria de Santiago and Universidade de Santiago de Compostela (USC), Galicia, Spain.
10
University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.
11
Pediatric Office Dr. Renáta Růžková, Prague, Czech Republic.
12
Instituto Hispalense de Pediatría, Sevilla, Spain.
13
CAP Centelles, Barcelona, Spain.
14
Hospital de Antequera, Málaga, Spain.
15
National Institute of Health Research Wellcome Trust Clinical Research Facility, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.
16
GSK, Bangalore, India.
17
GSK, Rockville, Maryland.

Abstract

BACKGROUND:

It has not yet been demonstrated whether 2 doses of inactivated quadrivalent influenza vaccine (IIV4) prime a booster response in infants. We evaluated the anamnestic immune response to an IIV4 in children 17-48 months of age.

METHODS:

Children were randomized to 2 doses of IIV4 or control in the primary phase III study (NCT01439360). One year later, in an open-label revaccination extension study (NCT01702454), a subset of children who received IIV4 in the primary study (primed group) received 1 IIV4 dose and children who received control in the primary study (unprimed) received 2 IIV4 doses 28 days apart. The primary objective was to evaluate hemagglutination inhibition (HI) antibody titers 7 days after first IIV4 vaccination in the per-protocol cohort (N = 224 primed; N = 209 unprimed). Neutralizing and antineuraminidase antibodies were also measured. Safety was analyzed in the total vaccinated cohort (N = 241 primed; N = 229 unprimed).

RESULTS:

An anamnestic response was observed in primed children relative to unprimed controls, measured by age-adjusted geometric mean HI titer ratios against strains homologous (A/H1N1: 9.0; B/Victoria: 3.9) and heterologous (A/H3N2: 2.7; B/Yamagata: 6.7) to those in the primary vaccination series. The anamnestic response in primed children included increases in neutralizing antibodies (mean geometric increase: 5.0-10.6) and antineuraminidase antibodies (4.9-8.8). No serious adverse events related to vaccination were reported.

CONCLUSIONS:

In this study, 2-dose priming with IIV4 induced immune memory that was recalled with 1-dose IIV4 the following year to boost HI, antineuraminidase and neutralizing antibodies, even though the IIV4 strain composition partially changed.

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