title: Safety and immunogenicity of an intramuscular quadrivalent influenza vaccine in children 3 to 8 y of age: A phase III randomized controlled study.
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.
authors: a Sanofi Pasteur , Marcy-l'Étoile , France.
authors: Stephanie
authors: S
authors: Pepin
authors: b Department of Pediatrics , St. Hedvig of Silesia Hospital , Trzebnica , Poland.
authors: Henryk
authors: H
authors: Szymanski
authors: c Centro de Investigación Clínica del Pacífico (CICPA) , Acapulco, Guerrero , Mexico.
authors: Ilya Angélica
authors: IA
authors: Rochín Kobashi
authors: d Instituto Nacional de Pediatria, Centro Pediátrico de Investigación Comunitario-Tlaltizapan , Tlaltizapan , Morelos , Mexico.
authors: Sandra
authors: S
authors: Villagomez Martinez
authors: e Instituto Nacional de Pediatria, Unidad de Apoyo a la Investigación Clinica - Planta Baja Insurgentes Sur #3700-C , Coyoacán, Mexico , D.F.
authors: José Francisco
authors: JF
authors: González Zamora
authors: f Zespół Opieki Zdrowotnej , Poradnia Chorób Zakaźnych , Dębica , Poland.
authors: Jerzy
authors: J
authors: Brzostek
authors: g National Taiwan University Hospital, Department of Pediatrics , Division of Infectious Diseases 7 , Taipei , Taiwan, R.O.C.
authors: Li-Min
authors: LM
authors: Huang
authors: h Department of Pediatrics , Chang Gung Children's Hospital, Chang Gung University , Kweishan, Taoyuan , Taiwan, R.O.C.
authors: Cheng-Hsun
authors: CH
authors: Chiu
authors: i Taichung Veterans General Hospital , Taichung , Taiwan, R.O.C.
authors: Po-Yen
authors: PY
authors: Chen
authors: j Vaccine Research Centre , University of Tampere Medical School , Tampere , Finland.
authors: Anitta
authors: A
authors: Ahonen
authors: j Vaccine Research Centre , University of Tampere Medical School , Tampere , Finland.
authors: Aino
authors: A
authors: Forstén
authors: j Vaccine Research Centre , University of Tampere Medical School , Tampere , Finland.
authors: Ilkka
authors: I
authors: Seppä
authors: k Hospital Infantil de Tlaxcala , Calle 20 de Noviembre s/n, Carretera a San Damian Tlacocalpan, Km. 2.5 San Matías Tepetomatitlan, Municipio de Apetatitlan de Antonio Carvajal, Tlaxcala , Mexico.
authors: René Farfán
authors: RF
authors: Quiroz
authors: j Vaccine Research Centre , University of Tampere Medical School , Tampere , Finland.
authors: Tiina
authors: T
authors: Korhonen
authors: l Sanofi Pasteur , Coyoacan , Cd de Mexico , D.F.
authors: Enrique
authors: E
authors: Rivas
authors: a Sanofi Pasteur , Marcy-l'Étoile , France.
authors: Celine
authors: C
authors: Monfredo
authors: m Sanofi Pasteur , Singapore.
authors: Yanee
authors: Y
authors: Hutagalung
authors: m Sanofi Pasteur , Singapore.
authors: Josemund
authors: J
authors: Menezes
authors: j Vaccine Research Centre , University of Tampere Medical School , Tampere , Finland.
authors: Timo
authors: T
authors: Vesikari
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D007273:Injections, Intramuscular; D008297:Male; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: children; haemagglutination inhibition; immunogenicity; phase III clinical trial; quadrivalent inactivated influenza vaccine; safety