CompletedPhase 2

A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

Australia, Poland, Spain538 participantsStarted 2009-02

Plain-language summary

The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.

Who can participate

Age range

11 Years – 18 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 male or female subjects between the ages of \>=11 and \<=18 years at the time of enrollment. * Negative urine pregnancy test for all female subjects. * Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation. Exclusion Criteria: * History of any invasive meningococcal disease. * A previous anaphylactic or severe vaccine-associated adverse reaction. * Any clinically significant chronic disease. * A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed. * Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.

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

Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2

Timeframe: Before vaccination 1 up to 1 month after vaccination 2

Timeframe: Before vaccination 1 up to 1 month after vaccination 3

Percentage of Participants With Atleast One Adverse Event (AE): Stage 1

Timeframe: Vaccination 1 upto 1 Month after vaccination 3

Percentage of Participants With Atleast One Adverse Event (AE): Stage 2

Timeframe: 6 month after vaccination 3 up to 48 months

Trial details

NCT IDNCT00808028

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-03

Results submitted2015-03-27

View on ClinicalTrials.gov More Meningitis, Meningococcal trials