Study to Evaluate the Immunogenicity and Safety of Hantavax in Healthy Adult

Green Cross Corporation

Status and phase

Unknown

Phase 3

Conditions

Healthy

Treatments

Biological: Hantavax injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT02553837

GC3101B_P3

Details and patient eligibility

About

This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating Hantavax in Healthy Adult.

Full description

This clinical trial was designed as a multicenter, non-comparative, open-label clinical trial. This trial was conducted, written informed consent form by voluntary agreement, the subjects who have not had the hantavax vaccination history at the time of screening. Investigator product was administrated 0, 1, 2, 13 months.

For antibody test, Sampling was conducted pre-dose(T0), 28 days after the 2nd vaccination(before the 3rd vaccination, T1), 28 days after the 3rd vaccination(T2) and 11 months after the 3rd vaccination(before booster vaccination, T3), 28 days after the booster vaccination(T4), 2 months after the booster vaccination(T5) and 4 months after the booster vaccination(T6). Also, after the completion of booster vaccination for antibody retention duration observed for subjects with antibody to conduct a five-year follow-up survey was conducted, and the antibody test every year. In conclusion, sampling was conducted 12 months(T7), 24 months(T8), 36months(T9), 48 months(T10), 60 months(T11) after the booster vaccination.

However, follow-up survey was terminated when the antibody titer was determined as a negative by neutralizing antibody test and fluorescent antibody technique.

Enrollment

317 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adults ≥ 19years old.
Subjects who have not the hantavax vaccination history at the time of screening.

Exclusion criteria

Subject who did not passed by 2 weeks after recovering the acute disease.
immunologic dysfunction subjects.
Subjects previously treated with anti-coagulant therapy or hemophiliac patients.
Subjects with severe chronic diseases.
Subjects who had an acute before vaccinating IP.
Subjects who had received another vaccination during the 28 days before vaccinating IP or who were scheduled for another vaccination during the study.
Subjects who were receiving immunosuppressant or immune modifying drug
Subjects who had been administered immunoglobulins or blood-derived products 3 months before vaccinating IP or who were scheduled for the administration during the study.
Subjects of childbearing potential at the time of screening and were scheduled to pregnancy for the study. A female subject who was pregnant or who was breast-feeding