Influenza
Conditions
Keywords
CCIV, quadrivalent cell-culture based influenza vaccine, Influenza vaccine, Vaccination
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.
Interventions
BIOLOGICALGC3106(quadrivalent cell-culture based influenza vaccine)
GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1
BIOLOGICALFluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)
Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
Sponsors
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unsolicited adverse events: Day 0~Day 21 | Day 0~Day 21 | — |
| The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio | 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 | Day 21 post vaccination | (SCR control drug- SPR test drug) |
| Solicited adverse events: Day 0~Day 6 | Day 0~Day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed