A Multicenter, Double-blind, Parallel Phase III Study
- Conditions
- Influenza
- Interventions
- Biological: GC Flu(Trivalent)Biological: GC3110A(Quadrivalent)Biological: GC3110A(Trivalent)
- Registration Number
- NCT02352584
- Lead Sponsor
- Green Cross Corporation
- Brief Summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III
- Detailed Description
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine) After Intramuscular Administration in Healthy Subjects
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1299
- Given written informed consent
- Healthy Korean adults (age: over 19 )
- Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures
- Those who are able to comply with the requirements for the study
- Inability in written/verbal communication
- Subjects who have participated in other interventional study within 30 days
- Alcohol or drug abuse within 6 months
- Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
- Disorders in immune function
- History of Guillain-Barré syndrome
- Disease/medications which are likely to cause any severe bleeding
- Active infection or experience of fever (>38.0 ℃) within 72 hours following vaccination
- Oral temperature >38.0 ℃ at the vaccination day
- Erythema, tattoo, injury at shoulder (vaccination site)
- Hypersensitivity with egg, chicken, or any of the vaccine components, or Neomycin, Gentamicin
- Influenza vaccination within 6months
- Any vaccination within 30 days
- Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products, or anti-cancer chemotherapy or radiation therapy within3 months
- Pregnant or breast-feeding women
- Clinically significant underlying diseases or medical history at investigator's discretion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GC Flu (Trivalent) GC Flu(Trivalent) 0.5ml,intramuscular,a single dosing GC3110A(Quadrivalent) GC3110A(Quadrivalent) 0.5ml, intramuscular, a single dosing GC3110A(Trivalent) GC3110A(Trivalent) 0.5ml,intramuscular,a single dosing
- Primary Outcome Measures
Name Time Method GMT rate of HI(Hemagglutination Inhibition) antibody for each strain Day 21 post vaccination GMT (Active comparator) / GMT(Experimental)
Solicited adverse events following vaccination Day0 up to 21 Day post vaccination Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia
Unsolicited adverse events following vaccination Day0 up to 21 Day post vaccination It can be estimated by Toxicity Grading Scale for healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain Day 21 post vaccination Difference of SCR (Experimental and Active comparator)
- Secondary Outcome Measures
Name Time Method SPR rate of HI(Hemagglutination Inhibition) antibody Day 21 post vaccination GMT rate of HI(Hemagglutination Inhibition) antibody for each strain Day 21 post vaccination SCR rate of HI(Hemagglutination Inhibition) antibody for each strain Day0 up to 21 Day post vaccination Abnormalities in physical examination, Vital signs, clinical laboratory tests Day 21 post vaccination SAE Day 180 post vaccination
Trial Locations
- Locations (1)
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of