Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
- Conditions
- Meningococcal Disease
- Interventions
- Biological: rMenB+OMV
- Registration Number
- NCT02141516
- Lead Sponsor
- Novartis
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 239
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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C rMenB+OMV age-matched healthy controls Group B rMenB+OMV asplenia/splenic dysfunction Group A rMenB+OMV Complement deficiency
- Primary Outcome Measures
Name Time Method 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. Day 1 and Day 91 (one month after the second dose of the study vaccine) Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain. Day 1 and Day 91 (one month after the second dose of the study vaccine). Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. Day 1 and Day 91 (one month after the second dose of the study vaccine). Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule. Day 1 and Day 91 (one month after the second dose of the study vaccine). Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953. Day 91 (one month after the second dose of the study vaccine). Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Number Of Subjects With Unsolicited Adverse Events (AEs). At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91) Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).
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. Day 91 (one month after the second dose of the study vaccine). Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule. Day 1 and Day 91 (one month after the second dose of the study vaccine). Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule. Day 1 and Day 91 (one month after the second dose of the study vaccine). Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
- Secondary Outcome Measures
Name Time Method Number of Subjects Reporting Solicited Local and Systemic AEs. From Day 1 until Day 7 after any vaccination. Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.
Trial Locations
- Locations (20)
31, Novartis Investigational Site
🇵🇱Krakow, Poland
33, Novartis Investigational Site
🇵🇱Warszawa, Poland
30, Novartis Investigational Site
🇵🇱Wroclaw, Poland
42, Novartis Investigational Site
🇷🇺Moscow, Russian Federation
41, Novartis Investigational Site
🇷🇺Moscow, Russian Federation
43, Novartis Investigational Site
🇷🇺Yekaterinburg, Russian Federation
13, Novartis Investigational Site
🇮🇹Roma, Italy
23, Novartis Investigational Site
🇪🇸Madrid, Spain
52, Novartis Investigational Site
🇬🇧Manchester, United Kingdom
22, Novartis Investigational Site
🇪🇸Madrid, Spain
53, Novartis Investigational Site
🇬🇧London, United Kingdom
21, Novartis Investigational Site
🇪🇸Barcelona, Spain
20, Novartis Investigational Site
🇪🇸Santiago De Compostela, Spain
24, Novartis Investigational Site
🇪🇸Valencia, Spain
51, Novartis Investigational Site
🇬🇧Southampton, United Kingdom
50, Novartis Investigational Site
🇬🇧Oxford, United Kingdom
12, Novartis Investigational Site
🇮🇹Firenze, Italy
10, Novartis Investigational Site
🇮🇹Milano, Italy
11, Novartis Investigational Site
🇮🇹Genova, Italy
14, Novartis Investigational Site
🇮🇹Padova, Italy