Study of egg-derived influenza vaccine and cell culture-derived influenza vaccine in healthy adult volunteers
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0001240
- Lead Sponsor
- SK Chemicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) Healthy adults aged 20 to 59 years who can be followed up during study period.
2) The subjects who gave written consent to participate in the study voluntarily and comply with all study requirements.
3) If the subject is female,she must be of post-menopausal and the subject has a negative urine pregnancy test result on screening.
1) Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
2) Subjects with immune deficiency disorder.
3) Prior personal history of Guillain-Barre syndrome.
4) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
5) Subjects who experienced fever within 24 hours before vaccination or with the febrile disease(axillary temperature exceeding 37.5?) on the visit date or with acute respiratory infection.
6) Subjects who had received immunosuppressant or immune modifying drug within 3 months before screening.
7) Subjects who had received blood products or immunoglobulin within 3 months before screening.
8) Subjects who had received influenza vaccination within 6 months prior to the screening.
9) Subjects who had received other vaccination within a month before screening, or those who had another vaccination scheduled within a month after vaccination with the investigational product.
10) Subjects who had participated in other clinical trial within 4 weeks prior to vaccination with the investigational product.
11) Subjects who had done blood donation within a week prior to vaccination with the investigational product or are planning to within 7 months.
12) Subjects with clinically significant chronic disease(e.g.; cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal dysfunction or hemoglobinopathy etc.) or malignant cancer.
13) Child-bearing women, Pregnant women, breast-feeding women.
14) Subjects with other clinically significant medical or psychological condition, who in the investigator's opinion may not suitable in participating in the study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants with Solicited Local AE;Percentage of participants with Solicited Systemic AE;Percentage of participants with Unsolicited AE ;Seroconversion rate;GMR(Geometric Mean Ratio);Seroprotection rate
- Secondary Outcome Measures
Name Time Method Vital signs;12-ECG;Physical examination;Clinical laboratory tests