학술논문
Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres.
Document Type
Academic Journal
Author
Pepin S; Sanofi Pasteur, Marcy-l'Étoile, France. Electronic address: Stephanie.Pepin@sanofipasteur.com.; Dupuy M; Sanofi Pasteur, Marcy-l'Étoile, France. Electronic address: Martin.Dupuy@sanofi.com.; Borja-Tabora CFC; Research Institute for Tropical Medicine, Muntinlupa City, Philippines.; Montellano M; Mary Chiles General Hospital, Manila, Philippines.; Bravo L; University of the Philippines Manila - National Institutes of Health, Manila, Philippines.; Santos J; Philippine Children's Medical Center, Quezon City, Philippines. Electronic address: jimson2@me.com.; de Castro JA; DLSUMC De La Salle Health Sciences Institute, Dasmariñas, Cavite, Philippines.; Rivera-Medina DM; Inversiones en Investigación Médica S.A, Tegucigalpa, Honduras.; Cutland C; Chris Hani Baragwanath Hospital, Johannesburg, South Africa. Electronic address: cutlandc@rmpru.co.za.; Ariza M; Caimed Dominicana A.S. Investigacion en Salud, Santo Domingo, Dominican Republic.; Diez-Domingo J; FISABIO-Public Health, Valencia, Spain.; Gonzalez CD; Hospital Infantil La Paz, Madrid, Spain. Electronic address: celiac.diaz@salud.madrid.org.; Martinón-Torres F; Translational Pediatrics and Infectious Diseases, Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Genetics, Vaccines and Infectious Diseases Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago, Universidad de Santiago, Spain. Electronic address: Federico.Martinon.Torres@sergas.es.; Papadopoulou-Alataki E; School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece. Electronic address: efiala@otenet.gr.; Theodoriadou M; Children's Hospital Aghia Sofia, Athens, Greece. Electronic address: mpapagrig@med.uoa.gr.; Kazek-Duret MP; Sanofi Pasteur, Marcy-l'Étoile, France. Electronic address: Marie-Pierre.Kazek-Duret@sanofi.com.; Gurunathan S; Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: Sanjay.Gurunathan@sanofi.com.; De Bruijn I; Sanofi Pasteur, Marcy-l'Étoile, France. Electronic address: Iris.DeBruijn@sanofi.com.
Source
Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
Subject
Language
English
Abstract
Background: A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra™, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged ≥ 3 years. This study examined the efficacy and safety of IIV4 in children aged 6-35 months.
Methods: This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6-35 months not previously vaccinated against influenza were randomised to receive two full doses 28 days apart of IIV4, placebo, the licensed trivalent split-virion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains.
Results: The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36-61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07-81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo.
Conclusions: IIV4 was safe and effective for protecting children aged 6-35 months against influenza illness caused by vaccine-similar or any circulating strains.
Clinical Trial Registration: EudraCT no. 2013-001231-51.
(Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Methods: This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6-35 months not previously vaccinated against influenza were randomised to receive two full doses 28 days apart of IIV4, placebo, the licensed trivalent split-virion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains.
Results: The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36-61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07-81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo.
Conclusions: IIV4 was safe and effective for protecting children aged 6-35 months against influenza illness caused by vaccine-similar or any circulating strains.
Clinical Trial Registration: EudraCT no. 2013-001231-51.
(Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)