Phase 3
Completed N=2,249
Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers
Source: ClinicalTrials.gov NCT00847145 ↗Enrolled (actual)
2,249
Serious AEs
5.0%
Results posted
Mar 2015
Primary outcomePrimary: Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination — 81; 82; 100; 100 Percentages of subjects
Summary
The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination |
81; 82; 100; 100; 98; 100 | — |
| SECONDARY Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination |
0; 0; 98; 99; 0; 0 | — |
| SECONDARY The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination |
11; 10; 139; 119; 81; 81 | — |
| SECONDARY Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) |
1.15; 1.15; 1.15; 1.14; 91; 83 | — |
| SECONDARY Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) |
3; 3; 3; 4; 100; 99 | — |
| SECONDARY Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) |
11; 1.18; 140; 15; 83; 1 | — |
| SECONDARY SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule |
1.24; 1.22; 271; 248; 1.06; 1.03 | — |
| SECONDARY Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule |
5; 3; 100; 100; 1; 1 | — |
| SECONDARY ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months |
390; 389; 6225; 5608 | — |
| SECONDARY ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers |
20; 22; 113; 120; 5698; 7154 | — |
| SECONDARY Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months |
84; 59; 100; 100 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age |
113; 104; 639; 673; 97; 80 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination |
211; 92; 212; 90; 158; 67 | — |
| SECONDARY Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age |
56; 39; 68; 353; 120; 52 | — |
| SECONDARY Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age |
50; 23; 17; 147; 6; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13
Exclusion Criteria
- 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/ alteration of the immune system,
- Receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment.
Data sourced from ClinicalTrials.gov (NCT00847145). 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.