Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inactivated hepatitis A vaccine | Experimental | A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months. |
|
| Havrix Inj | Active Comparator | A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated hepatitis A vaccine | Biological | Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | Seroconversion criteria: Anti-HAV 20 IU/L or above | 1 month after the second administration of the investigational product |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody titer (GMT) | The basic statistics of the antibody titer (GMT) at 1 month after the second vaccination | 1 month after the second vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints 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, physica | 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, physical examination |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| HJ Cho | BORYUNGPHARM. CO., LTD. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Incheon St.Mary's Hospital | Incheon | Bupyeong-gu | 403-720 | South Korea | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Havrix Inj | Biological | 720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj) |
|
| Approximately 12 months after a consent to the participation |
| The Catholic University of Korea, St.Vincent's Hospital. |
| Suwon |
| Gyeonggi-do |
| 442-723 |
| South Korea |
| Korea University Ansan Hospital | Ansan | 15355 | South Korea |
| Chanwon Fatima Hospital | Changwon | 51394 | South Korea |
| KeiMyung University Dongsan Medical Center | Daegu | South Korea |
| Gachon University Gil Hospital | Incheon | South Korea |
| Hanil General Hospital | Seoul | 01450 | South Korea |
| Korea cancer center Hospital | Seoul | 01812 | South Korea |
| Nowon Eulji Medical center , Eulji University | Seoul | 01830 | South Korea |
| Wonju Sevrance Christian Hospital | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided