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

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

Conditions

Meningitis, Meningococcal

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Further Details

Primary Outcome Measures:

  • Local & systemic safety throughout the trial

Secondary Outcome Measures:

  • Evidence of an immune response 1 month after dose 2 & 1 month after dose 3

Study Start

March 2006

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years – 25 Years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers

Inclusion Criteria:

  • Healthy 18-25 year olds

Exclusion Criteria:

  • Prior history of vaccination with any meningococcal vaccine
  • Prior history of any invasive meningococcal disease

Total Enrolment

108

Contact Details

  • Herson, Queensland, 4006, Australia
  • North Adealaide, South Australia, 5006, Australia
  • Perth, Western Australia, 6840, Australia

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