A Study Evaluating Safety and Immunogenicity of Meningococcal B rLP2086 Vaccine in Adolescents

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

Conditions

• Meningitis
• Meningococcal

Study Type

Interventional

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

539

Contact Details