Clinical trial
Prevention, Randomized, Open Label, Active Control, Parallel Assignment…
NCT00381615 · Novartis Vaccines, Industry · Completed
Key facts
| NCT number | NCT00381615 |
|---|---|
| Title | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official title | A Phase 2, Open Label, Multi-Center, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine±OMV, When Administered to Healthy Infants at 2, 4, 6 and/or 12 Months of Age |
| Lead sponsor | Novartis Vaccines, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Healthy |
| Intervention type | Biological |
| Interventions | rMenB, rMenB+OMV, DTaP-Hib-IPV, PC7, MenC-CRM, MenC-Hib, MMR |
| Enrollment | 147 |
| Start date | Sep 1, 2006 |
| Primary completion | Jul 1, 2007 |
| Completion | Aug 1, 2008 |
| First posted | Sep 28, 2006 |
| Last update posted | Oct 9, 2015 |
| Countries | United Kingdom |
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: