Trials / Completed
CompletedNCT00619502
Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
Immunogenicity and Safety Study of a Booster Dose of DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series at 2, 3 and 4 Months of Age in Healthy Turkish Infants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 254 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 15 Months – 18 Months
- Healthy volunteers
- Accepted
Summary
This is a follow-up of Study A3L10 (NCT00315055) Immunogenicity * To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP\~T or PENTAXIM™ and ENGERIX B®. * To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP\~T. Safety \- To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP\~T.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DTaP-IPV-HB-PRP~T vaccine | 0.5 mL, intramuscular (IM) |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2008-07-01
- Completion
- 2008-07-01
- First posted
- 2008-02-21
- Last updated
- 2016-05-13
- Results posted
- 2014-04-03
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT00619502. Inclusion in this directory is not an endorsement.