Healthy Clinical Trial
Official title:
Study to Evaluate the Immunogenicity and Safety of Hantavax in Healthy Adult
This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating Hantavax in Healthy Adult.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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