Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meningitis, Meningococcal, Serogroup B
Intervention: Meningococcal serogroup B vaccine (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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).
Clinical Details
Official title: A Primary Vaccination Study to Evaluate Immunogenicity, Safety & Reactogenicity of 3 Doses of GSK Biologicals/Finlay’s Meningococcal B Candidate Vaccine Given Intramuscularly Using Either 0-2-4 Mth or 0-1-6 Mth Schedule to Healthy Subjects Aged 12-18 Yrs
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: For each MenB strain assayed, pre and 1m post dose 2 and 3: SBA seropositivity, titer and immune response (post dose 2 only)After each vaccination: grade 3 and any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30) Serious adverse events [SAEs] (whole study)
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.
Eligibility
Minimum age: 12 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Valencia, Spain
Additional Information
Starting date: July 2002
Last updated: November 22, 2006
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