Hepatitis A Vaccine Clinical Trial
Official title:
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 Korean Healthy Children Aged 12~23 Months
The purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.
The objective of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose (administered twice in total at an interval of 6 months) of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months. 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03654677 -
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)
|
Phase 3 | |
| Completed |
NCT02712359 -
This Study Will Evaluate the Persistence of Hepatitis A Antibodies, 8 Years and 10 Years Later, in Children Who Had Received Havrix at Selected Health Centres of Panama
|
N/A |