CompletedPhase 3

A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive.

Germany13 participantsStarted 2013-08

Plain-language summary

The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).

Who can participate

Age range

18 Years – 65 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

. 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment;
. Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
. In good health as determined by medical history, physical examination and clinical judgment of the investigator;
. Who are or might be routinely exposed to cultures of N. meningitidis serogroup B.

Exclusion criteria

. Pregnancy or nursing (breastfeeding) mothers;
. Females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device 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 for at least 60 days prior to study entry;

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

Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule

Timeframe: Day1 and Day 91

Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule

Timeframe: Day1 and Day 91

Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.

Timeframe: Day1 and Day91

Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.

Timeframe: Day1 and Day91

Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.

Timeframe: Day 91

Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule

Timeframe: Day 1 and Day 91

Trial details

NCT IDNCT01911221

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-04

Results submitted2014-10-16

View on ClinicalTrials.gov More Prevention of the Meningococcal Disease trials

Who can participate

Age range

18 Years – 65 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

. 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment;
. Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
. In good health as determined by medical history, physical examination and clinical judgment of the investigator;
. Who are or might be routinely exposed to cultures of N. meningitidis serogroup B.

Exclusion criteria

. Pregnancy or nursing (breastfeeding) mothers;
. Females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device 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 for at least 60 days prior to study entry;

What they're measuring

Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule

Timeframe: Day1 and Day 91

Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule

Timeframe: Day1 and Day 91

Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.

Timeframe: Day1 and Day91

Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.

Timeframe: Day1 and Day91

Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.

Timeframe: Day 91

Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule

Timeframe: Day 1 and Day 91