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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1112-2680 | Other Identifier | WHO |
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The purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIMâ„¢) as a booster dose during the 4th and 6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi pasteur DTacP-IPV// PRP~T vaccine (PENTAXIMâ„¢) as a three-dose primary and booster vaccinations.
Primary Objective :
Secondary Objectives :
All participants that previously completed the three-dose primary and the booster vaccinations in the study E2I34 (NCT 00255021) will be contacted to enroll in this study to receive sanofi pasteur's DTacP IPV combined vaccine (Tetraximâ„¢) at 4 to 6 years of age.
Participants will receive the study vaccine [sanofi pasteur's DTacP-IPV vaccine (TETRAXIMâ„¢)] at 4 to 6 years of age (at visit 1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTacP-IPV combined vaccine (TETRAXIMâ„¢) | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of TETRAXIMâ„¢ after booster vaccination. | 30 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the safety after booster administration of TETRAXIMâ„¢. | 30 days post-vaccination and entire study period |
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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 | 10330 | Thailand | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23077849 | Derived | Pancharoen C, Chotpitayasunondh T, Chuenkitmongkol S, Ortiz E. Long-term immunogenicity assessment of a DTaP-IPV//PRP-T vaccine given at 2, 4, 6 and 18-19 months of age, and immunogenicity and safety of a DTaP-IPV vaccine given as a booster dose at 4 to 6 years of age in Thai children. Southeast Asian J Trop Med Public Health. 2012 May;43(3):687-98. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Bangkok |
| 10400 |
| Thailand |
| 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 |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |