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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Serogroup B Meningococcal Meningitis
- Sponsor
- Novartis Vaccines
- Enrollment
- 3630
- Locations
- 66
- Primary Endpoint
- The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy 2-month old infants (55-89 days, inclusive)
Exclusion Criteria
- •Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens)
- •Previous ascertained or suspected disease caused by N. meningitidis
- •History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- •Any serious chronic or progressive disease
- •Known or suspected impairment or alteration of the immune system
Outcomes
Primary Outcomes
The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)(1 month after the third vaccination)
- Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ(1 Month after the third vaccination)
- Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)(1 month after third vaccination)
- Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations(1 month after third vaccination)
- Percentages of Subjects With Antibody Response Against the Routine Antigens(1 Month after third vaccination)
- Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens(5 months)
- Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination(1 Month after third vaccination)
- Percentage of Subjects With hSBA Titers ≥1:8(1 month after third vaccination)
- Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine(upto 7 days after any vaccination)