Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
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| ClinicalTrials.gov Identifier: NCT02141516 |
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Recruitment Status :
Completed
First Posted : May 19, 2014
Results First Posted : February 15, 2017
Last Update Posted : February 15, 2017
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Sponsor:
Novartis
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Meningococcal Disease | Biological: rMenB+OMV | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 239 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Immunocompromised Patients From 2 to 17 Years of Age Who Are at Increased Risk of Meningococcal Disease Because of Complement Deficiency or Asplenia Compared to Matched Healthy Controls. |
| Study Start Date : | May 2014 |
| Actual Primary Completion Date : | March 2015 |
| Actual Study Completion Date : | March 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Complement factor I deficiency
Isolated congenital asplenia
Complement component 8 deficiency
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group A
Complement deficiency
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Biological: rMenB+OMV
2 doses of vaccine 2 months apart |
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Experimental: Group B
asplenia/splenic dysfunction
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Biological: rMenB+OMV
2 doses of vaccine 2 months apart |
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Active Comparator: Group C
age-matched healthy controls
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Biological: rMenB+OMV
2 doses of vaccine 2 months apart |
Primary Outcome Measures :
- 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
- 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
- Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953. [ Time Frame: 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). [ Time Frame: 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).
Secondary Outcome Measures :
- Number of Subjects Reporting Solicited Local and Systemic AEs. [ Time Frame: 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.
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| Ages Eligible for Study: | 2 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141516
Locations
Show 20 study locations
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
| Study Chair: | Novartis Vaccines | Novartis Vaccines |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT02141516 |
| Other Study ID Numbers: |
V72_62 2013-002454-78 ( EudraCT Number ) |
| First Posted: | May 19, 2014 Key Record Dates |
| Results First Posted: | February 15, 2017 |
| Last Update Posted: | February 15, 2017 |
| Last Verified: | July 2016 |
Keywords provided by Novartis:
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Meningitis vaccination complement deficiency asplenia splenic dysfunction |
Additional relevant MeSH terms:
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Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Infections |