Clinical trial
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B…
NCT00362427 · Sanofi Pasteur, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT00362427 |
|---|---|
| Title | Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar® |
| Official title | A Randomized Trial to Assess the Immunogenicity and Safety of PR5I With an Adjuvant Composition Enhancement to the Hepatitis B Component and When Given Concomitantly With Prevnar® |
| Lead sponsor | Sanofi Pasteur, a Sanofi Company, Industry |
| Collaborators | Merck Sharp & Dohme LLC Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Diphtheria, Pertussis, Polio, Hepatitis B, Tetanus |
| Intervention type | Biological |
| Interventions | Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC |
| Enrollment | 460 |
| Start date | Aug 1, 2006 |
| Primary completion | Feb 1, 2009 |
| Completion | Mar 1, 2009 |
| First posted | Aug 10, 2006 |
| Last update posted | Jan 14, 2014 |
| Countries | Canada |
At a glance
- No 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: