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

NCT02658409 | Unknown Phase 3 DMC

• 1 other identifier: GC3106_AD_P3
• Study Type: interventional
• Target: 1,630
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza

Keywords

CCIV; quadrivalent cell-culture based influenza vaccine; Influenza vaccine; Vaccination

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Solicited adverse events: Day 0~Day 6

  Day 0~Day 6

• Unsolicited adverse events: Day 0~Day 21

  Day 0~Day 21

Secondary Outcomes (4)

• 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

• For 180 days after Visit 1, serious adverse events were presented with the results.

  For 180 days after Visit 1

Study Arms (2)

GC3106(quadrivalent)

EXPERIMENTAL

0.5ml, intramuscular, a single dosing

Biological: GC3106(quadrivalent cell-culture based influenza vaccine)

Fluarix™tetra Syringe Inj.(Quadrivalent)

ACTIVE COMPARATOR

0.5ml,intramuscular,a single dosing

Biological: Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)

Interventions

GC3106(quadrivalent cell-culture based influenza vaccine) BIOLOGICAL

GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1

Also known as: GC3106

GC3106(quadrivalent)

Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine) BIOLOGICAL

Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1

Also known as: Fluarix™tetra Syringe Inj.

Fluarix™tetra Syringe Inj.(Quadrivalent)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Green Cross Corporation: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Lee Jin Su, M.D

  Inha University Hospital

  STUDY DIRECTOR

• Choi Won Seck, M.D

  Korea University Ansan Hospital

  STUDY DIRECTOR

• Lee Ja Cob

  Hallym Univ. Medical Center

  STUDY DIRECTOR

• Woo Heong Jung

  Hallym Univ. Medical Center

  STUDY DIRECTOR

• Wi Sung Heon

  St Vincent's Hospital

  STUDY DIRECTOR

• Jeong Suk In

  Chonnam Natinal University Hospital

  STUDY DIRECTOR

• Kim Sin Woo

  Kyungpook National University Hospital

  STUDY DIRECTOR

• Kim Tae Hyung

  Soon Chun Hyang Univ. Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2015
• First Posted: January 18, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2015
• Last Updated: February 26, 2016

Record last verified: 2016-01

Locations

KR (1)