Clinical trial NCT02658409: A Multicenter, Double-blind, Parallel, Non-inferiority, Phase III Study
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Influenza
Keywords: CCIV
quadrivalent cell-culture based influenza vaccine
Influenza vaccine
Vaccination
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2016-01-18
Enrollment: 1630
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* 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

Primary outcomes:
measure: The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio
timeFrame: Day 21 post vaccination
measure: The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the difference between the SCRs
timeFrame: Day 21 post vaccination
measure: Solicited adverse events: Day 0~Day 6
timeFrame: Day 0~Day 6
measure: Unsolicited adverse events: Day 0~Day 21
timeFrame: Day 0~Day 21
Secondary outcomes:
measure: Rate of subjects achieving seroconversion, defined as post vaccination HI antibody titers
timeFrame: 21 days after vaccination
measure: Rate of subjects achieving seroprotection, defined as post vaccination HI antibody titers
timeFrame: 21 days after vaccination
measure: Vital sign and physical examination
timeFrame: For 180 days after Visit 1
measure: For 180 days after Visit 1, serious adverse events were presented with the results.
timeFrame: For 180 days after Visit 1
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Inha University Hospital
name: Lee Jin Su, M.D
role: STUDY_DIRECTOR
affiliation: Korea University Ansan Hospital
name: Choi Won Seck, M.D
role: STUDY_DIRECTOR
affiliation: Hallym Univ. Medical Center
name: Lee Ja Cob
role: STUDY_DIRECTOR
affiliation: Hallym Univ. Medical Center
name: Woo Heong Jung
role: STUDY_DIRECTOR
affiliation: St Vincent's Hospital
name: Wi Sung Heon
role: STUDY_DIRECTOR
affiliation: Chonnam Natinal University Hospital
name: Jeong Suk In
role: STUDY_DIRECTOR
affiliation: Kyungpook National University Hospital
name: Kim Sin Woo
role: STUDY_DIRECTOR
affiliation: Soon Chun Hyang Univ. Hospital
name: Kim Tae Hyung
role: STUDY_DIRECTOR
References: