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Immunogenicity and Reactogenicity of a Meningococcal B Outer Membrane Vesicle Vaccine Given in a 0,6,12 Month Schedule to Health UK Adults

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ClinicalTrials.gov Identifier: NCT00197795
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 28, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Elizabeth Miller, Public Health England

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 healthy UK adults.

Condition or disease Intervention/treatment Phase
Neisseria Meningitidis Biological: Meningococcal outer membrane vesicle vaccine "MenBVac" Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006




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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197795


Sponsors and Collaborators
Public Health England
Investigators
Principal Investigator: Elizabeth Miller, MBBS FRCPath Public Health England