Phase 3
N=239
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
Meningococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT02141516 ↗Enrolled (actual)
239
Serious AEs
2.9%
Results posted
Feb 2017
Primary outcome: Primary: Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. — 0; 12; 9; 6 Percentage of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rMenB+OMV (Biological)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. |
0; 12; 9; 6; 95; 100 | — |
| PRIMARY Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. |
0; 11; 8; 5; 92; 100 | — |
| PRIMARY Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. |
299; 207; 228; 245; 44; 56 | — |
| PRIMARY Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. |
0.87; 1.43; 1.26; 1.24; 263; 300 | — |
| PRIMARY Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. |
92; 100; 98; 98; 87; 94 | — |
| PRIMARY Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule. |
33; 25; 27; 27; 2039; 3418 | — |
| PRIMARY ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule. |
62; 138; 112; 111 | — |
| PRIMARY Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953. |
97; 98; 98; 98 | — |
| PRIMARY Number Of Subjects With Unsolicited Adverse Events (AEs). |
17; 38; 55; 34; 9; 19 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic AEs. |
12; 8; 20; 13; 33; 12 | — |
Summary
The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction. A group of healthy age-matched subjects will be enrolled to serve as a descriptive control for immunogenicity and safety.
Eligibility Criteria
Inclusion Criteria
Inclusion criterion applicable to All Groups
- Subjects aged 2 to 17 years (inclusive) at enrollment
- weighing at least 13 Kg at the time of enrollment
Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies
Inclusion criterion applicable to Group B
- Subjects at risk of meningococcal disease because of functional or anatomic asplenia
Inclusion criterion applicable to Group C - healthy subjects
Exclusion Criteria
Exclusion criteria applicable to All Groups (A, B and C)
- History of any previous immunization with a meningococcal B vaccine
- History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine
- Known HIV infection
- History of any progressive or severe neurologic disorder or seizure disorder
- Contraindication to intramuscular injection or blood drawn
- Females who are pregnant, planning a pregnancy or nursing (breastfeeding)
- Females of childbearing potential who have not used or do not plan to use acceptable birth control measures
- History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects
Exclusion criterion applicable to Groups A and B
- Previous known or suspected disease caused by N. meningitidis in the last year.
Exclusion criteria applicable to Group C
- Previous known or suspected disease caused by N. meningitidis
- Known or suspected impairment/alteration of the immune system
Data sourced from ClinicalTrials.gov (NCT02141516). 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.