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| Sponsored by: |
Sanofi-Aventis |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00254969 |
Purpose
The present clinical study will assess the immunogenicity and reactogenicity of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.
| Condition | Intervention | Phase |
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Diphtheria Tetanus Haemophilus Infections Pertussis Poliomyelitis |
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib |
Phase III |
| MedlinePlus related topics: | Diphtheria Polio and Post-Polio Syndrome Tetanus Whooping Cough |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, Im
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Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
Related Info 
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Related Info 
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| Responsible Party: | Sanofi pasteur, Inc. ( Medical Director ) |
| Study ID Numbers: | E2I43 |
| First Received: | November 15, 2005 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00254969 |
| Health Authority: | South Africa: Medicines Control Council |
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