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OpenTrials
Completed

NCT Number: NCT00197795

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

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.

Completed

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Key information

Conditions

Neisseria Meningitidis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meningococcal outer membrane vesicle vaccine "MenBVac"

Biological

Sponsors and collaborators

Lead sponsor

Public Health England

Other Gov

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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