A Randomized, Double-blind, Multi-center, Active Controlled, Parallel-designed, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Youths Above 16 Years or Adults
Overview
- Phase
- Phase 3
- Intervention
- inactivated hepatitis A vaccine
- Conditions
- Hepatitis A Vaccine
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 253
- Locations
- 12
- Primary Endpoint
- Seroconversion rate
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The objective of this study is to evaluate the safety and immunogenicity after one primary dose and one additional dose (administered twice at an interval of 6 months) of inactivated hepatitis A vaccine are administered in adolescents (16 years of age or older) or adults.
Detailed Description
For this, a two-group comparison study will be conducted using a previously approved inactivated hepatitis A vaccine (Havrix Inj., manufactured by GSK) as the control vaccine to prove that the immunogenicity of the test vaccine treatment group is not inferior to the control vaccine treatment group and to statistically confirm that there is no difference in safety.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females aged 16 years or older on the day of the first vaccination
- •No history of hepatitis A or having hepatitis A vaccination
- •Provided consent to the participation in the study voluntarily after receiving explanations about the objective, method, effect, etc. of this clinical study
- •Determined by the investigator to be able to be followed up during the study period
Exclusion Criteria
- •A positive result (Anti-HAV 20 IU/L or above) in an hepatitis A antibody test at the time of screening
- •Positive hepatitis type B antigen at the time of screening
- •The following blood test results at the time of screening
- •ALT: More than 1.5 times the upper limit of normal
- •AST: More than 1.5 times the upper limit of normal
- •Total bilirubin: More than 1.5 times the upper limit of normal
- •Tympanic temperature of 38°C or above within 48 hours prior to the vaccination or on the day of vaccination
- •Moderate to severe acute or chronic infectious disease on the day of vaccination
- •History of sensitivity to the following drugs: neomycin, formaldehyde, gentamicin sulfate, any preventive vaccines
- •Congenital or acquired immunodeficient disease, or receiving immunosuppressive therapy
Arms & Interventions
inactivated hepatitis A vaccine
Inactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84)
Intervention: inactivated hepatitis A vaccine
Havrix Inj
1440 ELISA/mL_Adult Inj.(Name of Viral strain: HM175 Inj)
Intervention: Havrix Inj
Outcomes
Primary Outcomes
Seroconversion rate
Time Frame: 1 month after the second vaccination
Seroconversion criteria: Anti-HAV 20 IU/L or above
Secondary Outcomes
- Seroconversion rate(1 month after the first vaccination)