Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccin… (NCT01894919) | Clinical Trial Compass
CompletedPhase 3
Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28
Hungary, Spain851 participantsStarted 2013-06
Plain-language summary
The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in groups I to III of the parent V72\_28 study.
This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72\_28 study.
Who can participate
Age range
35 Months – 12 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
. Healthy infants and children according to the following age groups:
. Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The age window is defined as the first day the subject turns 35 months of age up to the day before the subject turns 48 months of age),
. Healthy subjects 4 to 7 years of age (only applicable to group L) (The age window is defined as the first day the subject turns 4 years of age up to the day before the subject turns 8 years of age).
. Healthy subjects 8 to 12 years of age (only applicable to group M) (The age window is defined as the first day the subject turns 8 years of age up to the day before the subject turns 13 years of age).
. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
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
Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains
Timeframe: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
2
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains
Timeframe: At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects
3
The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains
Timeframe: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
4
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study.
Timeframe: At Day 1 in this study over one month after the completion of the vaccination course in the parent study
5
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study.
Timeframe: At Day 1 in this study over visit 1 in the vaccination course in the parent study
. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study;
. in good health as determined by medical history, physical examination, clinical judgment of the investigator.
. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
Exclusion criteria
. History of any serogroup B meningococcal vaccine administration;
. Previous known or suspected disease caused by N. meningitidis;
. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization;
. History of severe allergic reaction after previous vaccinations or hypersensitivity to any component of the vaccine;
. Pregnancy or nursing (breastfeeding) mothers;
. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited febrile seizure is acceptable).