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 Taiwanese Adults 65 Years of Age and Older

Phase 3 Completed 165 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Primary Objective: Immunogenicity: To describe the immune response induced by high-dose quadrivalent influenza vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in all participants. Safety: To describe the safety profile of all participants in each study groups.

Timeline

Start: 2020-11-10
Primary completion: 2021-02-09
Completion: 2021-02-09

Publications

Chen JY, Hsieh SM, Hwang SJ, Liu CS, Li X, Fournier M, Yeh TY, Yin JK, Samson SI. Immunogenicity and safety of high-dose quadrivalent influenza vaccine in older adults in Taiwan: A phase III, randomized, multi-center study. Vaccine. 2022 Oct 26;40(45):6450-6454. doi: 10.1016/j.vaccine.2022.09.078. Epub 2022 Oct 7.

Drugs

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

Indications

No indication recorded.