Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years

Phase 1/2 Completed 175 enrolled Sanofi Pasteur, a Sanofi Company Sanofi · collab

RandomizedSequentialDouble-blindPrevention

Summary

This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to \[\>=\] 65 years).

Timeline

Start: 2017-09-15
Primary completion: 2017-11-28
Completion: 2017-11-28

Publications

Background Sanchez L, Matsuoka O, Inoue S, Inoue T, Meng Y, Nakama T, Kato K, Pandey A, Chang LJ. Immunogenicity and safety of high-dose quadrivalent influenza vaccine in Japanese adults >/=65 years of age: a randomized controlled clinical trial. Hum Vaccin Immunother. 2020 Apr 2;16(4):858-866. doi: 10.1080/21645515.2019.1677437. Epub 2019 Nov 19.

Drugs

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

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years

Summary

Timeline

Publications

Drugs

Indications