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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-5789 | Other Identifier | WHO |
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The purpose of this study is to evaluate the long term immunogenicity produced in children by the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT 00362336).
Primary Objective: To describe the antibody long term persistence at 3.5 and 4.5 years of age following a 3 dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or CombAct-Hibâ„¢ + Oral poliovirus vaccine (OPV) + Engerixâ„¢ B vaccination at 6, 10 and 14 weeks of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hibâ„¢ + OPV at 15-18 months
All participants must have received the primary series of vaccinations and a booster vaccination in Study A3L15 (NCT 00362336).
Participants will receive no vaccination in this study but will undergo immunologic assessments at 3.5 and 4.5 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Participants previously received 3 doses and a booster dose of the investigational vaccine DTaP IPV Hep B PRP-T. | ||
| Group 2 | Participants previously received 3 doses CombAct-Hibâ„¢ + Engerixâ„¢ B + OPV and a booster dose of CombAct-Hibâ„¢ + Oral poliovirus vaccine (OPV) vaccine. | ||
| Group 3 | Participants previously received 3 doses DTaP IPV Hep B PRP-T; a dose of Engerixâ„¢ B at birth, and a booster dose of DTaP IPV Hep B PRP-T vaccine. |
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| Measure | Description | Time Frame |
|---|---|---|
| The antibody titers for each valence of DTaP-IPV-Hep B-PRP-T vaccine (except poliovirus) post-primary and booster vaccination. | Age 3.5 and 4.5 years after infant and booster vaccination |
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Inclusion Criteria :
Exclusion Criteria :
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Participants aged 3 years and a half on the day of inclusion and must have received the primary series of vaccinations and a booster vaccination in Study A3L15 (NCT 00362336). No vaccination will be provided or administered in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bertsham | 2013 | South Africa | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D006509 | Hepatitis B |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Johannesburg |
| South Africa |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |