Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs

Phase 2

Completed

• Conditions: Infections, Meningococcal

• Registration Number: NCT00137917
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrix™ (0-6 months) and Meningitec™ (month 1).

Detailed Description

The study is open; however, vaccines given to study group at 0-1-6 months and to control group will be administered in an observer-blind manner. 3 blood samplings for antibody testing: before vaccination and one month after the second and third vaccine doses.

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2005-08-26
• Study First Submitted QC: 2005-08-26
• Study First Posted: 2005-08-30
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 478

Inclusion Criteria

• Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination.
• Female subjects must be of non-childbearing potential.

Exclusion Criteria

• Previous vaccination against or history of meningococcal B or C, or hepatitis A disease or exposure to meningococcal B disease within last year.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• Family history of congenital or hereditary immunodeficiency.
• History of any neurologic disorders or seizures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Meningococcal serogroup B (MenB) immune response (i.e. at least a 4-fold increase in serum bactericidal activity [SBA] from pre-vaccination titer) at 1 month postvaccination for each MenB strain assayed

Secondary Outcome Measures

Name	Time	Method
After each vaccination: grade 3 and any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30)
For each MenB strain assayed, pre and 1m post dose 2 and 3: SBA seropositivity, titer and immune response (post dose 2 only)
Serious adverse events [SAEs] (whole study)