tetano
Editor, Senior Moderator
Vaccine. 2019 Aug 17. pii: S0264-410X(19)31066-7. doi: 10.1016/j.vaccine.2019.08.016. [Epub ahead of print]
[h=1]Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial.[/h] Chang LJ[SUP]1[/SUP], Meng Y[SUP]2[/SUP], Janosczyk H[SUP]2[/SUP], Landolfi V[SUP]2[/SUP], Talbot HK[SUP]3[/SUP]; QHD00013 Study Group.
[h=3]Author information[/h] 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.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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).
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] 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.
[h=4]CLINICAL TRIAL REGISTRATION:[/h] NCT03282240.
Copyright ? 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Clinical trial; Elderly adults; High-dose influenza vaccine; Immunogenicity; Quadrivalent influenza vaccine; Safety
PMID: 31431411 DOI: 10.1016/j.vaccine.2019.08.016
[h=1]Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial.[/h] Chang LJ[SUP]1[/SUP], Meng Y[SUP]2[/SUP], Janosczyk H[SUP]2[/SUP], Landolfi V[SUP]2[/SUP], Talbot HK[SUP]3[/SUP]; QHD00013 Study Group.
[h=3]Author information[/h] 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.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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).
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] 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.
[h=4]CLINICAL TRIAL REGISTRATION:[/h] NCT03282240.
Copyright ? 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Clinical trial; Elderly adults; High-dose influenza vaccine; Immunogenicity; Quadrivalent influenza vaccine; Safety
PMID: 31431411 DOI: 10.1016/j.vaccine.2019.08.016