To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)

Boryung

Status and phase

Completed

Phase 3

Conditions

Hepatitis A Vaccine

Treatments

Biological: inactivated hepatitis A vaccine

Biological: Havrix Inj

Study type

Interventional

Funder types

Industry

Identifiers

NCT03654677

BR-HAV-CT-302

Details and patient eligibility

About

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.

Full 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.

Enrollment

253 patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

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
Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination
uncontrolled epilepsy or neurological disorders
Administered with other vaccine within 4 weeks prior to the screening
Planned with other vaccine within 4 weeks after the vaccination date
Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the screening
Participated in another clinical study within 12 weeks prior to the screening, or currently participating
Pregnant women or breast-feeding women
Other reasons not specified above that, in the opinion of the principal investigator, may make the subject ineligible to participate in the study