Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromi… (NCT02141516) | Clinical Trial Compass
CompletedPhase 3
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
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.
Who can participate
Age range
2 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine)
2
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).
3
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).
4
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).
5
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.
Timeframe: Day 91 (one month after the second dose of the study vaccine).
6
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.