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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2022-07-31

Brief Summary

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

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment only

Drug: Hantavax injectionSchedule: The basic vaccination(0, 1, 2months) and The boost vaccination(13months)

Group Type EXPERIMENTAL

Hantavax injection

Intervention Type BIOLOGICAL

A single 0.5mL dose intramuscular or subcutaneous injection

Interventions

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Hantavax injection

A single 0.5mL dose intramuscular or subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes