KCT0001240
Completed
未知
A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of‘NBP607 (Trivalent Inactivated Cell-Culture Influenza Vaccine)’compared to egg-based influenza vaccine in healthy adult volunteers
SK Chemicals0 sites100 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Sponsor
- SK Chemicals
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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