Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: February 24, 2006
Last updated: December 3, 2007
Last verified: December 2007

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

Condition Intervention Phase
Meningitis, Meningococcal
Biological: MnB rLP2086
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Estimated Enrollment: 108
Study Start Date: March 2006
Study Completion Date: March 2007

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy 18-25 year olds

Exclusion Criteria:

  • Prior history of vaccination with any meningococcal vaccine
  • Prior history of any invasive meningococcal disease
  Contacts and Locations
Please refer to this study by its identifier: NCT00297687

Australia, Queensland
Herson, Queensland, Australia, 4006
Australia, South Australia
North Adealaide, South Australia, Australia, 5006
Australia, Western Australia
Perth, Western Australia, Australia, 6840
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia,
  More Information

No publications provided Identifier: NCT00297687     History of Changes
Other Study ID Numbers: 6108A1-500
Study First Received: February 24, 2006
Last Updated: December 3, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Healthy Adults
Meningococcal Vaccines

Additional relevant MeSH terms:
Meningitis, Meningococcal
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections processed this record on April 16, 2014