NCT00297687CompletedPhase 1
A Randomized, Placebo-Controlled, Double Blind, Phase 1 Trial of the Safety, Immunogenicity, and Tolerability of Ascending Doses of Meningococcal Group B rLP2086 Vaccine in Healthy Adults
Wyeth is now a wholly owned subsidiary of Pfizer3 sites in 1 country108 target enrollmentStarted: March 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 3
- Primary Endpoint
- Local & systemic safety throughout the trial
Study Overview
Brief Summary
To determine the safety & immunogenicity of a potential vaccine against meningococcal B disease
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy 18-25 year olds
Exclusion Criteria
- •Prior history of vaccination with any meningococcal vaccine
- •Prior history of any invasive meningococcal disease
Outcomes
Primary Outcomes
Local & systemic safety throughout the trial
Secondary Outcomes
- Evidence of an immune response 1 month after dose 2 & 1 month after dose 3
Investigators
Study Sites (3)
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