One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningo… (NCT01139021) | Clinical Trial Compass
CompletedPhase 3
One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age
Czechia, Finland508 participantsStarted 2010-06
Plain-language summary
One year antibody persistence after the fourth dose boost or two catch-up doses administered starting from 12 months of age and to evaluate the response to a a third dose boost or two catch-up dose starting at 24 months of age.
Who can participate
Age range
23 Months – 27 Months
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 male and female children, 23 to 27 months of age (naïve children)
* Available for all the visits scheduled in the study;
* For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
* Available for all the visits scheduled in the study;
* In good health as determined by medical history, physical examination, clinical judgment of the investigator.
* Healthy children who participated in the immunogenicity part of V72P13E1 and have received their last vaccination 12 months (-30/+60 days) before enrolment in V72P13E2;
* Who received all vaccinations with rMenB+OMV NZ in V72P13 and V72P13E1 according to the protocols;
* Who provided at least the blood sample one month after their fourth dose of rMenB+OMV NZ (groups B246\_12M12/B246\_12M13) or after their second dose of rMenB+OMV NZ (groups B13\_15\_27/B12\_14\_26) in V72P13E1 according to the protocol;
* For whom parent(s)/legal guardian(s) had given written informed consent after the nature of the study has been explained;
* In good health as determined by medical history, physical examination, clinical judgment of the investigator.
Exclusion Criteria:
* Subjects whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study;
* History of any meningococcal B vaccine administration;
* Previous ascertained or suspected disease caused by N. meningitid…
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
Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.
Timeframe: 12 months post booster (fourth) vaccination.
2
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.
Timeframe: 12 months post booster (fourth) vaccination.
3
Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.
Timeframe: 12 months post booster (fourth) vaccination.