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
Por:
Pepin S, Dupuy M, Borja-Tabora CFC, Montellano M, Bravo L, Santos J, de Castro JA, Rivera-Medina DM, Cutland C, Ariza M, Diez-Domingo J, Gonzalez CD, Martinón-Torres F, Papadopoulou-Alataki E, Theodoriadou M, Kazek-Duret MP, Gurunathan S, De Bruijn I and GQM05 Study Group
Publicada:
22 mar 2019
Ahead of Print:
14 dic 2018
Resumen:
Background: A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetre (TM), 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 splitvirion 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. (C) 2018 The Authors. Published by Elsevier Ltd.
Filiaciones:
Pepin S:
Sanofi Pasteur, Marcy-l'Étoile, France
Dupuy M:
Sanofi Pasteur, Marcy-l'Étoile, France
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
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
Ariza M:
Caimed Dominicana A.S. Investigacion en Salud, Santo Domingo, Dominican Republic
:
FISABIO-Public Health, Valencia, Spain
Gonzalez CD:
Hospital Infantil La Paz, Madrid, Spain
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
Papadopoulou-Alataki E:
School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
Theodoriadou M:
Children's Hospital Aghia Sofia, Athens, Greece
Kazek-Duret MP:
Sanofi Pasteur, Marcy-l'Étoile, France
Gurunathan S:
Sanofi Pasteur, Swiftwater, PA, USA
De Bruijn I:
Sanofi Pasteur, Marcy-l'Étoile, France
hybrid, Green Published
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