Lee-Jah Chang1, Ya Meng2, Helene Janosczyk2, Victoria Landolfi2, H Keipp Talbot3. 1. Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA. Electronic address: Lee-Jah.Chang@sanofi.com. 2. Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA. 3. Vanderbilt University Medical Center, 1161 21st Avenue South, Nashville, TN 37232, USA.
Abstract
BACKGROUND: A high-dose, split-virion inactivated trivalent influenza vaccine (IIV3-HD; Fluzone® High-Dose, Sanofi Pasteur) is available for adults ≥65 years of age. This study examined the safety and immunogenicity of a quadrivalent high-dose split-virion inactivated influenza vaccine (IIV4-HD). METHODS: This was a randomized, modified double-blind, active-controlled, multi-center trial in healthy adults ≥65 years of age. Subjects were randomized in a 4:1:1 ratio to receive a single intramuscular injection of IIV4-HD, the licensed IIV3-HD, or an IIV3-HD containing the alternate B-lineage strain. Hemagglutination inhibition (HAI), seroneutralisation, and anti-neuraminidase antibody titers were measured at baseline and day 28. Solicited reactions were collected for up to 7 days, unsolicited adverse events up to 28 days, and serious adverse events up to 180 days. The primary immunogenicity objective was to demonstrate that IIV4-HD induces HAI geometric mean titers (GMTs) and seroconversion rates that are non-inferior to those induced by IIV3-HD. Secondary objectives were to describe the safety of IIV4-HD and IIV3-HD and to demonstrate that IIV4-HD induces HAI GMTs and seroconversion rates that are superior to those induced by IIV3-HD not containing the same B-lineage strain. RESULTS: The study included 2670 adults ≥65 years of age. For all four strains, HAI GMTs and seroconversion rates induced by IIV4-HD were non-inferior to those induced by IIV3-HDs containing the same strains. For both B strains, HAI GMTs and seroconversion rates induced by IIV4-HD were superior to those induced by IIV3-HD not containing the same B-lineage strain. Seroneutralisation and anti-neuraminidase antibody responses, measured in a subset of subjects, were similar. No new safety concerns were identified, and the safety profiles of IIV4-HD and IIV3-HD were similar. CONCLUSIONS: Adding a second B strain in IIV4-HD resulted in improved immunogenicity against the added strain without compromising the immunogenicity of the other strains or the vaccine's tolerability. CLINICAL TRIAL REGISTRATION: NCT03282240.
RCT Entities:
BACKGROUND: A high-dose, split-virion inactivated trivalent influenza vaccine (IIV3-HD; Fluzone® High-Dose, Sanofi Pasteur) is available for adults ≥65 years of age. This study examined the safety and immunogenicity of a quadrivalent high-dose split-virion inactivated influenza vaccine (IIV4-HD). METHODS: This was a randomized, modified double-blind, active-controlled, multi-center trial in healthy adults ≥65 years of age. Subjects were randomized in a 4:1:1 ratio to receive a single intramuscular injection of IIV4-HD, the licensed IIV3-HD, or an IIV3-HD containing the alternate B-lineage strain. Hemagglutination inhibition (HAI), seroneutralisation, and anti-neuraminidase antibody titers were measured at baseline and day 28. Solicited reactions were collected for up to 7 days, unsolicited adverse events up to 28 days, and serious adverse events up to 180 days. The primary immunogenicity objective was to demonstrate that IIV4-HD induces HAI geometric mean titers (GMTs) and seroconversion rates that are non-inferior to those induced by IIV3-HD. Secondary objectives were to describe the safety of IIV4-HD and IIV3-HD and to demonstrate that IIV4-HD induces HAI GMTs and seroconversion rates that are superior to those induced by IIV3-HD not containing the same B-lineage strain. RESULTS: The study included 2670 adults ≥65 years of age. For all four strains, HAI GMTs and seroconversion rates induced by IIV4-HD were non-inferior to those induced by IIV3-HDs containing the same strains. For both B strains, HAI GMTs and seroconversion rates induced by IIV4-HD were superior to those induced by IIV3-HD not containing the same B-lineage strain. Seroneutralisation and anti-neuraminidase antibody responses, measured in a subset of subjects, were similar. No new safety concerns were identified, and the safety profiles of IIV4-HD and IIV3-HD were similar. CONCLUSIONS: Adding a second B strain in IIV4-HD resulted in improved immunogenicity against the added strain without compromising the immunogenicity of the other strains or the vaccine's tolerability. CLINICAL TRIAL REGISTRATION: NCT03282240.
Authors: Miguel Ángel Palacios-Pedrero; Albert D M E Osterhaus; Tanja Becker; Husni Elbahesh; Guus F Rimmelzwaan; Giulietta Saletti Journal: Front Immunol Date: 2021-05-12 Impact factor: 7.561
Authors: Maria Ganczak; Paulina Dubiel; Marzena Drozd-Dąbrowska; Ewelina Hallmann-Szelińska; Karol Szymański; Lidia B Brydak Journal: Int J Environ Res Public Health Date: 2019-11-14 Impact factor: 3.390
Authors: Kenneth E Schmader; Christine K Liu; Theresa Harrington; Wes Rountree; Heidi Auerbach; Emmanuel B Walter; Elizabeth D Barnett; Elizabeth P Schlaudecker; Chris A Todd; Marek Poniewierski; Mary A Staat; Patricia Wodi; Karen R Broder Journal: JAMA Netw Open Date: 2021-01-04
Authors: Niklas Dyrby Johansen; Daniel Modin; Joshua Nealon; Sandrine Samson; Camille Salamand; Carsten Schade Larsen; Brian L Claggett; Scott D Solomon; Martin J Landray; Gunnar H Gislason; Lars Køber; Jens Ulrik Stæhr Jensen; Pradeesh Sivapalan; Lasse Skafte Vestergaard; Palle Valentiner-Branth; Tyra Grove Krause; Tor Biering-Sørensen Journal: Pilot Feasibility Stud Date: 2022-04-21
Authors: A Gil de Miguel; E Redondo Marguello; J Díez Domingo; R Ortiz de Lejarazu; F Martinón Torres Journal: Rev Esp Quimioter Date: 2020-06-09 Impact factor: 1.553