Journal article
Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial
JB Cadorna-Carlos, T Nolan, CF Borja-Tabora, J Santos, MC Montalban, FJ de Looze, P Eizenberg, S Hall, M Dupuy, Y Hutagalung, S Pépin, M Saville
Vaccine | Published : 2015
Open access
Abstract
Background: Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate. Methods: This phase III, randomized, controlled, multicenter trial in children/adolescents (9 through 17 years) and adults (18 through 60 years) was conducted in Australia and in the Philippines in 2012. The study was double-blind for IIV4 lots and open-label for IIV4 vs IIV3. Children/adolescents were randomized ..
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Funding Acknowledgements
The authors thank all study participants and the parents of the children who participated. Thanks are extended to Dr. Maureen McKeirnan at the Brisbane South Central Research Centre, Carina Heights, Queensland, Australia for her participation in this study, and to research staff at each of the study sites in Australia: the Vaccine and Immunisation Research Group at the Murdoch Children's Research Institute, University of Melbourne (Research Manager Marita Kefford; research nurses, phlebotomists and vaccine logistics staff Sharon Trevorrow, Jacinta O'Keefe, Mairead Phelan, Jacinta Sonego, Janet Briggs, Marie West, Annmarie McEvoy, Clare Brophy, Jane Ryrie, and Judith Spotswood; study doctors Loretta Thorn, Nicole Rose, Naomi Clarke, and Rowena Christiansen; Principal Research Fellow and Associate Professor Jodie McVernon; and Maria Bisgnano of Melbourne Health for laboratory support); the National Centre for Immunisation Research and Surveillance at Children's Hospital at Westmead; the Brisbane South Clinical Research Centre in Carina Heights; AusTrials in Sherwood; Doctors of Ivanhoe in Ivanhoe; and Emeritus Research in Malvern East; and to those in the Philippines: the Lingga Health Center in Calamba Laguna City; the Research Institute for Tropical Medicine in Muntinlupa City; the Philippine Children's Medical Center in Quezon City; and the Our Lady of Remedies Clinic in Manila. The authors thank Stephen W. Hildreth, Branda T. Hu, and Katherine Fries at Sanofi Pasteur's Central Clinical Immunology Laboratory for their contributions to the serological testing. Medical writing services were provided by Kurt Liittschwager (4Clinics, Paris, France). Support for medical writing assistance and for this study was provided by Sanofi Pasteur. Sanofi Pasteur participated in study design; the collection, analysis, and interpretation of data; writing of the report; and the decision to submit the article for publication.