Hepatitis A Vaccine
Conditions
Keywords
Hepatitis A Vaccine
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.
Interventions
BIOLOGICALinactivated hepatitis A vaccine
A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.
BIOLOGICALHavrix Inj
A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate | 1 month after the second vaccination | Seroconversion criteria: Anti-HAV 20 IU/L or above |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate | 1 month after the first vaccination | Seroconversion rate at 1 month after the first vaccination |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoint (Adverse events) | Approximately 12 months after a consent to the participation | Adverse events observed within 30 minutes after vaccination, solicited adverse events/adverse drug reactions, and unsolicited adverse events/adverse drug reactions through a diary, serious adverse events/adverse drug reactions |
Countries
South Korea
Outcome results
None listed