A Multicenter, Double-blind, Parallel, Non-inferiority, Phase III Study

Influenza Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02658409
• Other study ID #: GC3106_AD_P3
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 6, 2015
• Last updated: February 25, 2016
• Start date: November 2015

Study information

• Verified date: January 2016
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1630
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

• Subjects who had been vaccinated with another vaccine within 30 days before the investigational product administration or had a scheduled vaccination during the clinical study period

• Subjects who had received an immunosuppressant, immunity-modifying drug, cytotoxic chemotherapy that can affect his or her immune system, or radiation therapy within 3 months before the investigational product administration

• Subjects receiving systemic steroids (more than 20 mg/day of prednisolone administered everyday over 14 days or more than 700 mg of a cumulative dose during the same period of time) within 3 months before the administration (Day 1) of the investigational product (topical ointments, eye drops, inhalants or intranasally/intramuscularly administered drugs, or topically applied drugs such as ligaments; unless administered every other day over 14 days)

• Subjects who had received immunoglobulin or a blood-derived product within 3 months before being vaccinated with the investigational product or is scheduled to receive those products during the clinical study period

• Pregnant women, nursing mothers, or women of childbearing age who do not perform adequate contraception (using a condom, diaphragm, IUD, or hormonal contraception 21 days before vaccination with the investigational product or whose male partner had undergone a vasectomy)

Subjects who have other clinically significant medical or psychiatric examination findings deemed by the investigator to make them ineligible for participation in this clinical study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• GC3106(quadrivalent cell-culture based influenza vaccine)
GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1
• Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)
Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio	(GMT control drug/ GMT test drug)	Day 21 post vaccination	No
Primary	The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the difference between the SCRs	(SCR control drug- SPR test drug)	Day 21 post vaccination	No
Primary	Solicited adverse events: Day 0~Day 6		Day 0~Day 6	No
Primary	Unsolicited adverse events: Day 0~Day 21		Day 0~Day 21	No
Secondary	Rate of subjects achieving seroconversion, defined as post vaccination HI antibody titers		21 days after vaccination	No
Secondary	Rate of subjects achieving seroprotection, defined as post vaccination HI antibody titers		21 days after vaccination	No
Secondary	Vital sign and physical examination		For 180 days after Visit 1	Yes
Secondary	For 180 days after Visit 1, serious adverse events were presented with the results.		For 180 days after Visit 1	Yes