Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
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
1 other identifier
interventional
108
1 country
3
Brief Summary
To determine the safety \& immunogenicity of a potential vaccine against meningococcal B disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2006
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2006
CompletedFirst Posted
Study publicly available on registry
February 28, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedDecember 5, 2007
December 1, 2007
February 24, 2006
December 3, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local & systemic safety throughout the trial
Secondary Outcomes (1)
Evidence of an immune response 1 month after dose 2 & 1 month after dose 3
Interventions
Eligibility Criteria
You may qualify if:
- Healthy 18-25 year olds
You may not qualify if:
- Prior history of vaccination with any meningococcal vaccine
- Prior history of any invasive meningococcal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Herson, Queensland, 4006, Australia
Unknown Facility
North Adealaide, South Australia, 5006, Australia
Unknown Facility
Perth, Western Australia, 6840, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Australia, medinfo@wyeth.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 24, 2006
First Posted
February 28, 2006
Study Start
March 1, 2006
Study Completion
March 1, 2007
Last Updated
December 5, 2007
Record last verified: 2007-12