Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents
Official Title
A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 micrograms, 60 micrograms, and 200 micrograms of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years
Conditions
Meningitis
Study Type
Interventional
Study Design
Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment
Further Details
- Primary Outcome Measures: Serum Bacteriocidal Activity
Study Start
October 2006
Eligibility & Criteria
- Ages Eligible for Study: 8 Years – 14 Years
- Genders Eligible for Study: Both
Inclusion Criteria
- Aged 8 to 14 years at the time of enrollment
- Healthy male or female subjects
- Negative urine pregnancy test for female subjects
Exclusion Criteria
- Prior vaccination with a meningococcal B vaccine
- Prior meningococcal disease
Total Enrolment
Contact Details
- Perth, Western Australia, 6840, Australia; Recruiting
- Trial Manager: clintrialparticipation@wyeth.com
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