Phase 3
Completed N=3,630
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Serogroup B Meningococcal Meningitis
Source: ClinicalTrials.gov NCT00657709 ↗
Enrolled (actual)
3,630
Serious AEs
8.0%
Results posted
Apr 2015
Primary outcomePrimary: The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination — 1.21; 1.19; 1.19; 87 Titers
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination |
1.21; 1.19; 1.19; 87; 98; 85 | — |
| PRIMARY The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) |
3; 3; 100; 3; 4; 7 | — |
| SECONDARY The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) |
4; 2; 3; 3; 100; 100 | — |
| SECONDARY Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ |
1.15; 1.12; 91; 1.2; 1.18; 1.21 | — |
| SECONDARY Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) |
22; 22; 22; 22; 21; 3149 | — |
| SECONDARY Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations |
9.98; 9.28; 123; 147; 6.3; 5.36 | — |
| SECONDARY Percentages of Subjects With Antibody Response Against the Routine Antigens |
38; 38; 100; 100; 2; 2 | — |
| SECONDARY Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens |
84; 87; 79; 88; 92; 95 | — |
| SECONDARY Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination |
99; 100; 98; 99; 1; 100 | — |
| SECONDARY Percentage of Subjects With hSBA Titers ≥1:8 |
2; 2; 2; 2; 2; 100 | — |
| SECONDARY Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine |
2388; 443; 2147; 266; 2049; 261 | — |
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
Data sourced from ClinicalTrials.gov (NCT00657709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.