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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1161-2649 | Other Identifier | WHO |
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Primary Objective:
To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.
Sera from subjects who have participated in study PNA19 trial (NCT00594347) and for whom parents or legal representatives had given authorization to use the sera taken from their child will be used for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Toddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12 |
|
| Group B | Experimental | Toddlers vaccinated with Infanrix hexa® in study A3L12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines | Biological | Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study | Levels of anti-Hepatitis B antibody concentrations will be determined at ≥ 10 mIU/mL and ≥ 100 mIU/mL | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | 10700 | Thailand | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29333947 | Result | Kosalaraksa P, Chokephaibulkit K, Benjaponpitak S, Pancharoen C, Chuenkitmongkol S, B'Chir S, Da Costa X, Vidor E. Persistence of hepatitis B immune memory until 9-10 years of age following hepatitis B vaccination at birth and DTaP-IPV-HB-PRP approximately T vaccination at 2, 4 and 6 months. Hum Vaccin Immunother. 2018 May 4;14(5):1257-1265. doi: 10.1080/21645515.2018.1426418. Epub 2018 Feb 21. |
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| DTaP-HB-IPV and Pneumococcal polysaccharide vaccines | Biological | Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study |
|
| Khon Kaen |
| 40002 |
| Thailand |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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