A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

Green Cross Corporation1 site in 1 country1,630 target enrollmentNovember 2015

ConditionsInfluenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: Green Cross Corporation
Enrollment: 1630
Locations: 1
Primary Endpoint: The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study.

Detailed Description

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (quadrivalent cell-culture based influenza vaccine) after Intramuscular Administration in Healthy Subjects.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

November 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Green Cross Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Given written informed consent
•Healthy Korean adults (age: between over 19)
•Women of childbearing age with negative Urine hCG in screening visit

Exclusion Criteria

•Subjects unable to communicate (illiterate or who cannot understand the questionnaire and/or the study subject diary)
•Subjects participating in another clinical study or has participated in a clinical study in the last 30 days (the participation should be based on the final dose of the investigational drug)
•Subjects with impaired immune functions that include immune deficiency diseases
•Subjects with a history of Guillain-Barre syndrome
•Hemophilia patients at risk of serious bleeding with intramuscular injection or who had taken an anticoagulant
•Subjects with symptoms of active infection or who had higher than 38.0℃ fever before the investigational product administration
•Subjects to be planned to have a surgery in the study duration or subject who the investigator decides exception because of a clinical significant chronic or malignant disease or medical history to interrupt the study procedure
•Subjects with erythema and/or a tattoo in the injection site of the scheduled investigational product (the deltoid muscle) that is hard to identify the topical toxicity
•Subjects with a history of allergic reaction to eggs or chicken, the vaccine components, and/or Formaldehyed, Gentamicin and Sodium Deoxychloate
•Subjects who had been administered the influenza vaccine 6 months before the scheduled vaccination of the investigational product

Outcomes

Primary Outcomes

The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio

Time Frame: Day 21 post vaccination

(GMT control drug/ GMT test drug)

The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the difference between the SCRs

Time Frame: Day 21 post vaccination

(SCR control drug- SPR test drug)

Solicited adverse events: Day 0~Day 6

Time Frame: Day 0~Day 6

Unsolicited adverse events: Day 0~Day 21

Time Frame: Day 0~Day 21

Secondary Outcomes

For 180 days after Visit 1, serious adverse events were presented with the results.(For 180 days after Visit 1)
Rate of subjects achieving seroconversion, defined as post vaccination HI antibody titers(21 days after vaccination)
Rate of subjects achieving seroprotection, defined as post vaccination HI antibody titers(21 days after vaccination)
Vital sign and physical examination(For 180 days after Visit 1)