A Phase I/?a Study to Investigate the Safety, Tolerability, and Immunogenicity of GC3106 (quadrivalent cell-culture based influenza vaccine) in Healthy Subjects
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0001261
- Lead Sponsor
- Green Cross
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 84
(1) Given written informed consent
(2) Healthy Korean adults (age: between over 19 and under 64)
(3) Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures
(4) Those who are able to comply with the requirements for the study
(1) Inability in written/verbal communication
(2) Subjects who have participated in other interventional study within 30 days
(3) Alcohol or drug abuse within 6 months
(4) Heavy drinkers or subjects who do not agree to stop drinking for 3 days before vaccination and other 3 days after vaccination
(5) Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
(6) Hypersensitivity with drug or active ingredient
(7) Disorders in immune function
(8) History of Guillain-Barré syndrome
(9) Disease/medications which are likely to cause any severe bleeding
(10) Active infection or experience of fever (>38.0 ?) within 72 hours following vaccination
(11) Oral temperature >38.0 ? at the vaccination day
(12) Subject with other clinically significant medical history of liver-biliary system, renal system, nervous system(central or peripheral), respiratory system(asthma, etc), endocrine system(diabetes, hyperlipidemia, etc), cardiovascular system(congestive heart failure, coronary heart disease, myocardial infarction, etc; except controllable hypertension), blood tumor, urinary system, psychiatry, musculoskeletal system, immune system(rheumatoid arthritis, systemic lupus erythematosus etc.) otolaryngologic disease who were considered by the investigator to be ineligible for the study
(13) Erythema, tattoo, injury at shoulder (vaccination site)
(14) Influenza vaccination within 6months
(15) Any vaccination within 30 days
(16) 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
(17) Pregnant or breast-feeding women
(18) Clinically significant underlying diseases or medical history at investigator's discretion
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Solicited adverse events following vaccination [ Time Frame: Day 1 up to 7 Days post vaccination ];Unsolicited adverse events following vaccination [ Time Frame: Day 1 up to 22 Days post vaccination ];Abnormalities in physical examination, vital signs, and/or clinical laboratory tests
- Secondary Outcome Measures
Name Time Method Seroprotection rate of Hemagglutination Inhibition antibody for each strain strain [ Time Frame: Day 22 post vaccination ] ;Seroconversion rate of Hemagglutination Inhibition antibody for each strain [ Time Frame: Day 22 post vaccination ];GMT(geometric mean titers) for each strain [ Time Frame: Day 22 post vaccination ]