NCT03718468 is a Phase 3 clinical trial of GC FLU Quadrivalent in Influenza, sponsored by Medigen Vaccine Biologics Corp..

Who is sponsoring NCT03718468?

NCT03718468 is sponsored by Medigen Vaccine Biologics Corp..

What drugs are being tested in NCT03718468?

Interventions in NCT03718468: GC FLU Quadrivalent, Fluarix Tetra.

Is NCT03718468 still recruiting?

NCT03718468 is currently completed. Last updated 14 August 2019.

Last reviewed 2019-08-14 · How we verify

NCT03718468

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 14 August 2019

What this trial tests

Phase 3 trial testing GC FLU Quadrivalent in Influenza in 842 participants. Completed in 3 July 2019.

Timeline

30 October 2018

Primary endpoint
3 July 2019

3 July 2019

Quick facts

Lead sponsor	Medigen Vaccine Biologics Corp.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	842
Start date	30 October 2018
Primary completion	3 July 2019
Estimated completion	3 July 2019
Sites	4 locations across Taiwan

Drugs / interventions tested

GC FLU Quadrivalent — full drug profile →
Fluarix Tetra — full drug profile →

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

Medigen Vaccine Biologics Corp. — full company profile →

Who can join

Adults 20 to 50, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Influenza

Currently open trials in the same condition.

NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults · Phase 3 · recruiting
NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
NCT07431840 — Immune Defense Protein Impact On Respiratory Immune Outcomes · NA · recruiting
NCT07485855 — Influenza Vaccination Strategy for Patients With Hematologic Malignancy · Phase 3 · recruiting

Other Medigen Vaccine Biologics Corp. trials

Trials by the same sponsor.

NCT07178522 — A Study to Evaluate the Immunogenicity and Safety of an EV71 Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compare · Phase 3 · recruiting
NCT05198596 — A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 in Adults Aged 18 Years and Above · Phase 3 · completed
NCT05426343 — A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Vaccine Compared With AZD1222 · Phase 3 · completed
NCT05216601 — A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19 · Phase 1 · completed
NCT05197153 — A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19 · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03718468 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medigen Vaccine Biologics Corp.
Last refreshed: 14 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03718468.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing