Clinical trial
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™…
NCT00313911 · Sanofi Pasteur, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT00313911 |
|---|---|
| Title | Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months. |
| Official title | Large Scale Safety Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American Infants |
| Lead sponsor | Sanofi Pasteur, a Sanofi Company, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Hepatitis B |
| Intervention type | Biological |
| Interventions | DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib |
| Enrollment | 2,133 |
| Start date | Jul 1, 2006 |
| Primary completion | Jan 1, 2008 |
| Completion | Feb 1, 2008 |
| First posted | Apr 12, 2006 |
| Last update posted | Apr 21, 2014 |
| Countries | Mexico, Peru |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: