Geoffrey J Gorse1, Ann R Falsey2, Ayca Ozol-Godfrey3, Victoria Landolfi4, Peter H Tsang5. 1. Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, 1100 S. Grand Boulevard, St. Louis, MO 63104, USA. Electronic address: gorsegj@slu.edu. 2. University of Rochester School of Medicine, Rochester General Hospital, Rochester, NY 14621, USA. Electronic address: ann.falsey@rochestergeneral.org. 3. Sanofi Pasteur, Inc., 1 Discovery Drive, Swiftwater, PA 18370, USA. Electronic address: ayca.ozol-godfrey@sanofipasteur.com. 4. Sanofi Pasteur, Inc., 1 Discovery Drive, Swiftwater, PA 18370, USA. Electronic address: victoria.landolfi@sanofipasteur.com. 5. Sanofi Pasteur, Inc., 1 Discovery Drive, Swiftwater, PA 18370, USA. Electronic address: peter.tsang@sanofipasteur.com.
Abstract
BACKGROUND: An 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. METHODS: This 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. RESULTS:1672 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. CONCLUSIONS:Antibody 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.
RCT Entities:
BACKGROUND: An 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. METHODS: This 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. RESULTS: 1672 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. CONCLUSIONS: Antibody 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.
Authors: Carine Claeys; Mamadou Drame; José García-Sicilia; Khalequ Zaman; Alfonso Carmona; Phu My Tran; Mariano Miranda; Federico Martinón-Torres; Franck Thollot; Michael Horn; Tino F Schwarz; Ulrich Behre; José M Merino; Iwona Sadowska-Krawczenko; Henryk Szymański; Peter Schu; Elisabeth Neumeier; Ping Li; Varsha K Jain; Bruce L Innis Journal: BMC Infect Dis Date: 2018-04-18 Impact factor: 3.090
Authors: Alice Mannocci; Andrea Pellacchia; Rossella Millevolte; Manuela Chiavarini; Chiara de Waure Journal: Int J Environ Res Public Health Date: 2022-08-01 Impact factor: 4.614
Authors: Lisa A Grohskopf; Leslie Z Sokolow; Sonja J Olsen; Joseph S Bresee; Karen R Broder; Ruth A Karron Journal: MMWR Morb Mortal Wkly Rep Date: 2015-08-07 Impact factor: 17.586
Authors: Sophie A Valkenburg; Nancy H L Leung; Maireid B Bull; Li-Meng Yan; Athena P Y Li; Leo L M Poon; Benjamin J Cowling Journal: Front Immunol Date: 2018-07-02 Impact factor: 7.561