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A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.
Details
| Lead sponsor | Novartis Vaccines |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 3630 |
| Start date | 2008-03 |
| Completion | 2010-01 |
Conditions
- Serogroup B Meningococcal Meningitis
Interventions
- Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
- Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
- Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
- Infanrix Hexa
- Menjugate
- Prevenar
Primary outcomes
- The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination — one month after the third vaccination
The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs). - The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) — one month after the third vaccination
The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.
Countries
Austria, Czechia, Finland, Germany, Italy