Safety and immunogenicity of an intramuscular quadrivalent influenza vaccine in children 3 to 8 y of age: A phase III randomized controlled study
Journal
Human Vaccines and Immunotherapeutics
Journal Volume
12
Journal Issue
12
Pages
3072-3078
Date Issued
2016
Author(s)
Pepin S.
Szymanski H.
Roch?n Kobashi I.A.
Villagomez Martinez S.
Gonz?lez Zamora J.F.
Brzostek J.
Chiu C.-H.
Chen P.-Y.
Ahonen A.
Forst?n A.
Sepp? I.
Quiroz R.F.
Korhonen T.
Rivas E.
Monfredo C.
Hutagalung Y.
Menezes J.
Vesikari T.
Abstract
A quadrivalent, inactivated, split-virion influenza vaccine containing a strain from both B lineages (IIV4) has been developed, but its safety and immunogenicity in young children has not been described. This was a phase III, randomized, double-blind, active-controlled, multi-center study to examine the immunogenicity and safety of IIV4 in children 3–8 y of age (EudraCT no. 2011-005374-33). Participants were randomized 5:1:1 to receive the 2013/2014 Northern Hemisphere formulation of IIV4, an investigational trivalent comparator (IIV3) containing the B/Victoria lineage strain, or the licensed Northern Hemisphere IIV3 containing the B/Yamagata lineage strain. Participants who had not previously received a full influenza vaccination schedule received 2 doses of vaccine 28 d apart; all others received a single dose. 1242 children were included. For all 4 strains, IIV4 induced geometric mean haemagglutination inhibition titres non-inferior to those induced by the IIV3 comparators. For both B strains, geometric mean antibody titres induced by IIV4 were superior to those induced by the IIV3 with the alternative lineage strain. Similar proportions of participants vaccinated with IIV4 and IIV3 reported solicited injection-site reactions, solicited systemic reactions, and vaccine-related adverse events. A single vaccine-related serious adverse event, thrombocytopenia, was reported 9 d after vaccination with IIV4 and resolved without sequelae. In conclusion, in children aged 3–8 y who received one dose or 2 doses 28 d apart, IIV4 had an acceptable safety profile, was as immunogenic as IIV3 for the shared strains, and had superior immunogenicity for the additional B strain. ? 2016 Taylor & Francis.
Subjects
children; haemagglutination inhibition; immunogenicity; phase III clinical trial; quadrivalent inactivated influenza vaccine; safety
SDGs
Other Subjects
influenza vaccine; inactivated vaccine; influenza vaccine; virus antibody; Article; child; cold sweat; controlled study; dizziness; double blind procedure; drug safety; ecchymosis; erythema; fatigue; female; fever; headache; hemagglutination inhibition; human; immunogenicity; influenza; injection site induration; injection site pain; injection site reaction; major clinical study; malaise; male; multicenter study; myalgia; oropharynx pain; pallor; phase 3 clinical trial; randomized controlled trial; rhinopharyngitis; sensitivity analysis; seroconversion; shivering; single drug dose; swelling; thrombocytopenia; upper respiratory tract infection; vomiting; blood; clinical trial; Drug-Related Side Effects and Adverse Reactions; hemagglutination inhibition test; immunology; Influenza, Human; intramuscular drug administration; preschool child; Antibodies, Viral; Child; Child, Preschool; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions; Female; Hemagglutination Inhibition Tests; Humans; Influenza Vaccines; Influenza, Human; Injections, Intramuscular; Male; Vaccines, Inactivated
Publisher
Taylor and Francis Inc.
Type
journal article