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A Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine

NCT03718468 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 842

Last updated 2019-08-14

No results posted yet for this study

Summary

This study aims to demonstrate the immunogenic efficacy of GC FLU Quadrivalent Pre-filled Syringe inj. (GC FLU), a quadrivalent influenza virus vaccine, is non-inferior to the active control, Fluarix Tetra. This study is designed to be a randomized, open-labelled, active-controlled, parallel, phase III study recruiting subjects from multiple study sites.

Approximately 840 eligible subjects are planned to enroll in order to obtain 800 evaluable (= per-protocol) subjects. Subjects will be randomized and assigned to GC FLU or Fluarix Tetra (active control, AC) group in 1:1 ratio.

Conditions

Interventions

BIOLOGICAL

GC FLU Quadrivalent

A single dose administration of GC FLU Quadrivalent will be through intramuscular injection.

BIOLOGICAL

Fluarix Tetra

A single dose administration of Fluarix Tetra will be through intramuscular injection.

Sponsors & Collaborators

  • Medigen Vaccine Biologics Corp.

    lead INDUSTRY

Principal Investigators

  • Szu-Min Hsieh, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2019-07-03
Completion
2019-07-03

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT03718468 on ClinicalTrials.gov