None listed
Conditions
Sponsors
SK Chemicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adults aged 19 years or older. 2) The subjects who gave written consent to participate in the study voluntarily and are able to comply with all study requirements. 3) If female and capable of bearing children,subject has a negative urine pregnancy test result on screening and agrees to employ adequate birth control measures through the study period.
Exclusion criteria
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(exceeding 38.0?) on screening day or with any 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 or malignant cancer. 13) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroprotection rate;Seroconversion rate;GMR(Geometric Mean Ratio);Percentage of participants with Solicited Local AE;Percentage of participants with Solicited Systemic AE ;Percentage of participants with Unsolicited AE;Percentage of participants with SAE | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity in subjects with a pre-vaccination HI antibody titer <1:80;Immunogenicity compared to control group;long-term immunogenicity evaluation;Vital sign;Physical examination;Clinical laboratory tests | — |
Countries
Korea, Republic of
Contacts
Public ContactMi Lee
Koera University Guro Hospital
Outcome results
None listed