Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Japanese Adults 60 Years of Age and Older

Phase 3 Completed 2100 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary Objective: To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition \[HAI\] geometric mean titers \[GMTs\] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants. Secondary Objective: * To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method in all participants. * To describe the safety profile of all participants in each study group.

Timeline

Start: 2020-10-21
Primary completion: 2021-01-14
Completion: 2021-01-14

Publications

Background Sanchez L, Nakama T, Nagai H, Matsuoka O, Inoue S, Inoue T, Shrestha A, Pandey A, Chang LJ, De Bruijn I; QHD00010 Study Group. Superior immunogenicity of high-dose quadrivalent inactivated influenza vaccine versus Standard-Dose vaccine in Japanese Adults >/= 60 years of age: Results from a phase III, randomized clinical trial. Vaccine. 2023 Apr 6;41(15):2553-2561. doi: 10.1016/j.vaccine.2023.02.071. Epub 2023 Mar 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine	Vaccine	0.5 ml	Subcutaneous
Subject	QIV-HD	Vaccine	0.7 ml	Intramuscular

Indications

No indication recorded.