CompletedPhase 2

Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults

Italy54 participantsStarted 2007-07

Plain-language summary

This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.

Who can participate

Age range

18 Years – 50 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 adults,18 through 50 years of age, who were or might be routinely exposed to N. meningitidis cultures Exclusion Criteria: * Previous ascertained or suspected disease caused by N. meningitidis; * Pregnancy or breastfeeding; * History of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; * Any present or suspected serious acute or chronic disease * Known or suspected autoimmune disease or impairment /alteration of immune function

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 Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.

Timeframe: One month after vaccinations

Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.

Timeframe: One month after vaccinations

Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination.

Timeframe: One month after vaccinations

Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination

Timeframe: One month after vaccinations

Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.

Timeframe: One month after vaccinations

Trial details

NCT IDNCT00560313

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2011-06-06

View on ClinicalTrials.gov More Meningococcal Disease trials

Who can participate

Age range

18 Years – 50 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.

What they're measuring

Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.

Timeframe: One month after vaccinations

Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.

Timeframe: One month after vaccinations

Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination.

Timeframe: One month after vaccinations

Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination

Timeframe: One month after vaccinations

Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.

Timeframe: One month after vaccinations