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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Elizabeth Miller, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00197795
First received: September 12, 2005
Last updated: March 27, 2012
Last verified: March 2012
History of Changes

September 12, 2005
March 27, 2012
January 2005
December 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00197795 on ClinicalTrials.gov Archive Site
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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
Not Provided

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Neisseria Meningitidis
Biological: Meningococcal outer membrane vesicle vaccine "MenBVac"
Not Provided
Findlow J, Taylor S, Aase A, Horton R, Heyderman R, Southern J, Andrews N, Barchha R, Harrison E, Lowe A, Boxer E, Heaton C, Balmer P, Kaczmarski E, Oster P, Gorringe A, Borrow R, Miller E. Comparison and correlation of neisseria meningitidis serogroup B immunologic assay results and human antibody responses following three doses of the Norwegian meningococcal outer membrane vesicle vaccine MenBvac. Infect Immun. 2006 Aug;74(8):4557-65. Erratum in: Infect Immun. 2007 Aug;75(8):4187.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00197795
MNB1
Not Provided
Dr. Elizabeth Miller, Health Protection Agency, United Kingdom
Health Protection Agency, United Kingdom
Not Provided
Principal Investigator: Elizabeth Miller, MBBS FRCPath Health Protection Agency, United Kingdom
Health Protection Agency, United Kingdom
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP