Back to resultsStudy Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
Primary Purpose
Meningitis, Meningococcal
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
MnB rLP2086
Sponsored by
About this trial
This is an interventional prevention trial for Meningitis, Meningococcal focused on measuring Vaccines, Healthy Adults, Health, Adult, Meningococcal Vaccines
Eligibility Criteria
Inclusion Criteria: Healthy 18-25 year olds Exclusion Criteria: Prior history of vaccination with any meningococcal vaccine Prior history of any invasive meningococcal disease
Sites / Locations
Outcomes
Primary Outcome Measures
Local & systemic safety throughout the trial
Secondary Outcome Measures
Evidence of an immune response 1 month after dose 2 & 1 month after dose 3
Full Information
NCT ID
NCT00297687
First Posted
February 24, 2006
Last Updated
December 3, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00297687
Brief Title
Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To determine the safety & immunogenicity of a potential vaccine against meningococcal B disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal
Keywords
Vaccines, Healthy Adults, Health, Adult, Meningococcal Vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
108 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
MnB rLP2086
Primary Outcome Measure Information:
Title
Local & systemic safety throughout the trial
Secondary Outcome Measure Information:
Title
Evidence of an immune response 1 month after dose 2 & 1 month after dose 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy 18-25 year olds
Exclusion Criteria:
Prior history of vaccination with any meningococcal vaccine
Prior history of any invasive meningococcal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Australia, medinfo@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Herson
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
City
North Adealaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6840
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
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