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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

NCT04537234 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-09-24

Study results available
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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.

Conditions

  • Influenza (Healthy Volunteers)

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04537234 on ClinicalTrials.gov