Status:
COMPLETED
Immunogenicity and Reactogenicity of a Meningococcal B Outer Membrane Vesicle Vaccine Given in a 0,6,12 Month Schedule to Health UK Adults
Lead Sponsor:
Public Health England
Conditions:
Neisseria Meningitidis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
To measure the serum bactericidal antibody levels and cell mediated immune responses before and six weeks after each dose of meningococcal outer membrane vesicle vaccine given at 0,6 and 12 weeks to h...
Eligibility Criteria
Inclusion
- Informed written consent given for three immunizations with MenBVac and five blood tests
- Between the ages of 18 and 55 years inclusive at recruitment
Exclusion
- Previous history of bacteriologically confirmed meningococcal disease
- History of clinically significant allergic sensitivity to any vaccine received in the past
- Immunodeficiency
- Any other acute or chronic systemic illness or dependence or abuse of drugs or alcohol
- Language difficulties sufficient to preclude adequate comprehension of the study information
- Possibility of pregnancy
- Receipt of any other vaccine in the previous 4 weeks
- Receipt of any group B vaccine in the past
- Current participation in any other clinical trial
- Generalized acute systemic illness and/or temp \>38C on day of vaccination deferral
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00197795
Start Date
January 1 2005
End Date
December 1 2006
Last Update
August 24 2018
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