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NCT00297687 Clinical Trial

Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults

Meningitis, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00297687
Other study ID # 6108A1-500
Secondary ID
Status Completed
Phase Phase 1
First received February 24, 2006
Last updated December 3, 2007
Start date March 2006
Est. completion date March 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

To determine the safety & immunogenicity of a potential vaccine against meningococcal B disease

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Healthy 18-25 year olds

Exclusion Criteria:

- Prior history of vaccination with any meningococcal vaccine

- Prior history of any invasive meningococcal disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• MnB rLP2086

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Local & systemic safety throughout the trial
Secondary Evidence of an immune response 1 month after dose 2 & 1 month after dose 3
See also
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