A Phase 3 interventional study of inactivated hepatitis A vaccine and Havrix Inj in Hepatitis A Vaccine, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 12 sites in Korea, Republic of. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 3, Interventional, and Prevention
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.
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.
2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 253 is above the median of 100 across 1,887 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The following blood test results at the time of screening
Inactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84)
Biological: inactivated hepatitis A vaccine
1440 ELISA/mL_Adult Inj.(Name of Viral strain: HM175 Inj)
Biological: Havrix 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.
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.
Seroconversion rate
Seroconversion criteria: Anti-HAV 20 IU/L or above
Time frame: 1 month after the second vaccination
Seroconversion rate
Seroconversion rate at 1 month after the first vaccination
Time frame: 1 month after the first vaccination
Safety endpoint (Adverse events)
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
Time frame: Approximately 12 months after a consent to the participation
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Boryung Pharmaceutical Co., Ltd