Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults |
| |
| Affiliation: | 1. Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, 1100 S. Grand Boulevard, St. Louis, MO 63104, USA;2. University of Rochester School of Medicine, Rochester General Hospital, Rochester, NY 14621, USA;3. Sanofi Pasteur, Inc., 1 Discovery Drive, Swiftwater, PA 18370, USA;1. Serum Institute of India Private Ltd., 212/2 Off Soli Poonawalla Road, Hadapsar, Pune, Maharashtra 411028, India;2. Viroclinics Biosciences B.V., Rotterdam Science Tower, Marconistraat 16, 3029 AK Rotterdam, the Netherlands;3. PATH, 2201 Westlake Avenue, Seattle, WA 98121, USA;1. Protein Sciences Corporation, Meriden, CT, United States;2. Yale University School of Medicine, New Haven, CT, United States;3. University of Colorado Denver School of Medicine, Aurora, CO, United States;4. Biologics Consulting Group, Inc., Bethesda, MD, United States;1. The Melbourne School of Population and Global Health and Murdoch Childrens Research Institute, University of Melbourne, Melbourne, Australia.;2. Queen Sirikit National Institute of Child Health, Bangkok, Thailand;3. Research Institute for Tropical Medicine, Muntinlupa City, Philippines;4. Southern Clinical Trials Ltd, Beckenham, Christchurch, New Zealand;5. Senders Pediatrics, Cleveland, OH, USA;6. Novartis Vaccines and Diagnostics GmbH, Marburg, Germany;7. Novartis Pharma BV, Amsterdam, The Netherlands;8. Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA;1. Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, 1100 S. Grand Boulevard, St. Louis, MO 63104, USA;2. University of Rochester School of Medicine, Rochester General Hospital, 1425 Portland Avenue, Infectious Diseases Unit, Rochester, NY 14621, USA;3. Primary Care Associates of Alabaster, 1022 1st Street North, Suite 400, Alabaster, AL 35007, USA;4. BioKinetic Clinical Applications, 1816 W. Mount Vernon Street, Springfield, MO 65802, USA;5. Omega Medical Research, 400 Bald Hill Road # 528, Warwick, RI 02886, USA;6. The Center for Pharmaceutical Research, 1010 Carondelet Drive #426, Kansas City, MO 64114, USA;7. Sanofi Pasteur, Inc., 1 Discovery Drive, Swiftwater, PA 18370, USA;8. Department of Pediatrics, University of Pittsburgh, 3550 Terrace Street, Pittsburgh, PA 15261, USA;1. School of Public Health and Community Medicine, University of New South Wales, NSW, Sydney, Australia;2. College of Public Service & Community Solutions, Arizona State University, Phoenix, AZ, United States;1. Center for Clinical Epidemiology & Population Health, Marshfield Clinic Research Institute, Marshfield, WI, United States;2. Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, United States |
| |
| Abstract: | BackgroundAn intradermal (ID) trivalent split-virion influenza vaccine (IIV3-ID) (Fluzone® Intradermal, Sanofi Pasteur, Swiftwater, PA) has been available in the US since the 2011/2012 influenza season for adults aged 18–64 years. This study examined whether adding a second B-lineage strain affects immunogenicity and safety.MethodsThis randomized, double-blind, multicentre trial evaluated the immunogenicity and safety of an intradermal quadrivalent split-virion influenza vaccine (IIV4-ID) in adults 18–64 years of age in the US during the 2012–2013 influenza season. Participants were randomized 2:1:1 to receive a single injection of IIV4-ID, licensed IIV3-ID, or an investigational IIV3-ID containing the alternate B-lineage strain. Haemagglutination inhibition antibody titres were assessed in two-thirds of participants before vaccination and 28 days after vaccination.Results1672 participants were vaccinated with IIV4-ID, 837 with licensed IIV3-ID, and 846 with an investigational IIV3-ID. For all four vaccine strains, antibody responses to IIV4-ID were statistically non-inferior to the response to the IIV3-ID vaccines containing the matched strains. For both B strains, post-vaccination antibody responses to IIV4-ID were statistically superior to the responses to IIV3-ID lacking the corresponding B strain. Adverse events were similar for IIV4-ID and IIV3-ID. The most commonly reported solicited reactions were pain, pruritus, myalgia, headache, and malaise; and most were grade 1 or 2 and appeared and resolved within 3 days of vaccination. IIV4-ID was statistically non-inferior to the two pooled IIV3-ID vaccines for the proportions of participants with at least one grade 2 or 3 systemic reaction.ConclusionsAntibody responses to the IIV4-ID were non-inferior to IIV3-ID for the A and matched B strains and superior for the unmatched B strains. IIV4-ID was well tolerated without any safety concerns. IIV4-ID may help address an unmet need due to mismatched B strains in previous influenza vaccines. |
| |
| Keywords: | Quadrivalent influenza vaccine Intradermal Immunogenicity Safety Phase III Adults AE" },{" #name" :" keyword" ," $" :{" id" :" kw0045" }," $$" :[{" #name" :" text" ," _" :" adverse event CI" },{" #name" :" keyword" ," $" :{" id" :" kw0055" }," $$" :[{" #name" :" text" ," _" :" confidence interval GMT" },{" #name" :" keyword" ," $" :{" id" :" kw0065" }," $$" :[{" #name" :" text" ," _" :" geometric mean titer HA" },{" #name" :" keyword" ," $" :{" id" :" kw0075" }," $$" :[{" #name" :" text" ," _" :" hemagglutinin HAI" },{" #name" :" keyword" ," $" :{" id" :" kw0085" }," $$" :[{" #name" :" text" ," _" :" hemagglutination inhibition ID" },{" #name" :" keyword" ," $" :{" id" :" kw0095" }," $$" :[{" #name" :" text" ," _" :" intradermal IIV3-ID" },{" #name" :" keyword" ," $" :{" id" :" kw0105" }," $$" :[{" #name" :" text" ," _" :" intradermal trivalent inactivated influenza vaccine IIV3-ID1" },{" #name" :" keyword" ," $" :{" id" :" kw0115" }," $$" :[{" #name" :" text" ," _" :" licensed IIV3-ID IIV3-ID2" },{" #name" :" keyword" ," $" :{" id" :" kw0125" }," $$" :[{" #name" :" text" ," _" :" investigational IIV3-ID containing the alternate B lineage IIV4-ID" },{" #name" :" keyword" ," $" :{" id" :" kw0135" }," $$" :[{" #name" :" text" ," _" :" intradermal quadrivalent inactivated influenza vaccine IIV4-IM" },{" #name" :" keyword" ," $" :{" id" :" kw0145" }," $$" :[{" #name" :" text" ," _" :" intramuscular quadrivalent inactivated influenza vaccine IM" },{" #name" :" keyword" ," $" :{" id" :" kw0155" }," $$" :[{" #name" :" text" ," _" :" intramuscular SAE" },{" #name" :" keyword" ," $" :{" id" :" kw0165" }," $$" :[{" #name" :" text" ," _" :" serious adverse event |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
