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To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to healthy infants, as measured by seroprotection/vaccine response rates 4-8 weeks post-final immunisation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group with 0-2-4-6 schedule | Experimental | HB at 0, Eutravac at 2-4-6 |
|
| Active comparator group with 0-2-4-6 schedule | Active Comparator | Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB) |
|
| Experimental group with 2-4-6 schedule | Experimental | Eutravac at 2-4-6 |
|
| Active comparator group with 2-4-6 schedule | Active Comparator | Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eutravac | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection rate | After final immunisation at 4-8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daejeon St. Mary's Hospital | Daejeon | Daejeon | 301-723 | South Korea | ||
| The Catholic University of Korea ST. Vincent's Hospital |
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|
| Suwon |
| Gyeonggi-do |
| 442-723 |
| South Korea |
| Inha University Hospital | Incheon | Incheon | 400-711 | South Korea |
| Jeju National University Hospital | Jeju City | Jeju-do | 690-767 | South Korea |
| Kyung Hee University Hospital | Seoul | Seoul | 130-872 | South Korea |
| Cha Hospital | Seoul | Seoul | 135-913 | South Korea |
| Korea Cancer Center Hospital | Seoul | Seoul | 139-709 | South Korea |
| ID | Term |
|---|---|
| C484909 | Euvax-B |
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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