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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00297687 |
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Date of registration:
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24/02/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
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Scientific title:
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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 |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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108 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00297687 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Australia, medinfo@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy 18-25 year olds
Exclusion Criteria:
- Prior history of vaccination with any meningococcal vaccine
- Prior history of any invasive meningococcal disease
Age minimum:
18 Years
Age maximum:
25 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Meningitis, Meningococcal
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Intervention(s)
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Biological: MnB rLP2086
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Primary Outcome(s)
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Local & systemic safety throughout the trial
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Secondary Outcome(s)
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Evidence of an immune response 1 month after dose 2 & 1 month after dose 3
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Secondary ID(s)
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6108A1-500
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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