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.

Official Title

A Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B rLP2086 Vaccine at Doses of 60 Mcg, 120 Mcg, and 200 Mcg in Healthy Adolescents Aged 11 to 18 Years


  • Meningitis
  • Meningococcal

Study Type


Study Design

Prevention, Randomised, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study

Further Details

Primary outcome measures 

  • Adverse events will be monitored throughout the study to evaluate the safety and tolerability of rLP2086. The Serum Bactericidal Assay (SBA) will be used to measure the primary immunogenicity objective.
    [ Time Frame: SBA assay results are expected throughout the study period. The first SBA results are expected for June 2009. ]
    [ Designated as safety issue: Yes ]

Study Start

February 2009 – March 2014

Eligibility & Criteria

  • Ages eligible for study: 11 years to 18 years
  • Genders eligible for study: Both
  • Accepts healthy volunteers: Yes

Inclusion criteria

  1. Healthy male or female subjects between the ages of ≥11 and ≤18 years at the time of enrollment.
  2. Negative urine pregnancy test for all female subjects.
  3. 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

  1. History of any invasive meningococcal disease.
  2. A previous anaphylactic or severe vaccine-associated adverse reaction.
  3. Any clinically significant chronic disease.
  4. 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.
  5. Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.

This study is ongoing, but not recruiting participants.

Total Enrolment


Contact Details

All content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.