NCT04537234

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

Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine in Subjects 65 Years of Age and Older in Taiwan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The duration of each participant's participation was approximately 28 days (Day 0 through Day 28 \[+ 7 days\]).

Conditions

• Influenza (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	High-Dose Quadrivalent Influenza Vaccine	Pharmaceutical form: Suspension for injection in pre-filled syringe, Route of administration: IM
BIOLOGICAL	Standard-Dose Quadrivalent Influenza Vaccine	Pharmaceutical form: Suspension for injection in pre-filled syringe, Route of administration: IM

Timeline

• Start date: 2020-11-10
• Primary completion: 2021-02-09
• Completion: 2021-02-09
• First posted: 2020-09-03
• Last updated: 2025-09-24
• Results posted: 2021-11-08

Locations

4 sites across 1 country: Taiwan