Trials / Completed
CompletedNCT00254969
Immunogenicity and Safety of Pentaxim in South African Infants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 212 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 24 Hours
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib | 0.5 mL, Im |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2008-05-01
- Completion
- 2010-01-01
- First posted
- 2005-11-17
- Last updated
- 2012-04-17
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT00254969. Inclusion in this directory is not an endorsement.