Phase III clinical study to evaluate the effectiveness(immunogenicity) and safety of ‘GC501(influenza split vaccine)’
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0000034
- Lead Sponsor
- Green Cross
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1397
1)Healthy adults 18 years of age and older who can be followed up for 21 days.
2)Subjects who gave voluntary written consent to participate in the study, and are able to comply with the study requirements.
1)Subjects with a known history of hypersensitivity or allergic reaction to eggs or egg products, to chicken or chicken products, to any component of the study vaccine, neomycin or gentamicin
2)Subjects with immune system disorder, including immune deficiency disease
3)Subjects with a history of Guillain-Barre syndrome
4)Subjects with severe chronic disease (e.g.; cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal dysfunction or hemoglobinopathy etc.) who in the investigator’s opinion may have a difficulty in participating in the study.
5)Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.
6)Subjects who had acute fever with the body temperature exceeding 38.0? within 72 hours before vaccination with the study drug.
7)Subjects who had received other vaccination within 7 days before vaccination with the study drug, or those who had another vaccination scheduled during the study.
8)Subjects who had received immunosuppressant or immune modifying drug within 3 months before vaccination with the study drug.
9)Subjects who had received immunoglobulin or blood products within 3 months before vaccination with the study drug or are planning to receive them during the study.
10)Subjects who had received influenza vaccination within 6 months prior to the vaccination with the study drug
11)Pregnant women, breast-feeding women or women of childbearing potential who do not use an appropriate method of contraception (use of condom, intrauterine contraceptive device, or hormone contraceptives, or if a male partner had vasectomy)
12)Subjects who had participated in other clinical study within 30 days prior to vaccination with the study drug.
13)Subjects with other clinically significant medical or psychological condition, who in the investigator’s opinion are not suited for the study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoints_The percentage of subjects achieving seroconversion for HI antibody (Seroconversion rate) ;Primary efficacy endpoints_?The percentage of subjects achieving a post-vaccination HI antibody titer = 1:40 (Seroprotection rate);Primary safety endpoints_Solicited adverse events(Day 0 ~ 6);Primary safety endpoints_Unsolicited adverse events(Day 0 ~ 21)
- Secondary Outcome Measures
Name Time Method Secondary efficacy endpoints_GMT (Geometric Mean Titer) and GMR (Geometric Mean Ratio) of HI antibody titer before vaccination (Day 0) and after vaccination (Day 21).;Secondary efficacy endpoints_The percentage of subjects with a pre-vaccination (Day 0) HI antibody titer <1:40, and a minimum four-fold rise in post-vaccination (Day 21) HI antibody titer ;Secondary safety endpoints- Vital signs and physical examination, and the results of laboratory test (haematology/blood chemistry test, urine test).