NCT02553837

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 317 (estimated)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Hantavax injection	A single 0.5mL dose intramuscular or subcutaneous injection

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-08-01
• Completion: 2022-07-01
• First posted: 2015-09-18
• Last updated: 2016-02-02