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The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
This study is a two-group comparative study using a marketed inactivated hepatitis A vaccine (HAVRIX®, manufactured by GSK) as a control. The study will demonstrate non-inferiority of the test vaccine compared to the control vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Inactivated Hepatitis A vaccine |
|
| Control group | Active Comparator | Inactivated Hepatitis A vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL | Biological | Dosage and administration: pre-iflled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HAV seroconversion rate at 4 weeks after the second vaccination | Seroconversion: anti-HAV ≥ 20 mIU/mL after the second vaccination in subjects with anti-HAV < 20 mIU/mL at baseline | At Visit 6 (7 months after Day 1: first vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination | GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination | At Visit 6 (7 months after Day 1: first vaccination) |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seoyeon Hong, BS | Contact | +82-2-740-4087 | brbio_co@boryungbio.co.kr | |
| Hari Jeon, PharmD | Contact | +82-2-740-4228 | hrjeon@boryungbio.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, ST. Vincent's Hospital | Suwon | 16247 | South Korea |
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| HAVRIX 720 Junior 0.5 mL | Biological | Dosage and administration: pre-filled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval. |
|
| GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination | GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination | At Visit 6 (7 months after Day 1: first vaccination) |
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | Thailand |
|
| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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