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

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ClinicalTrials.gov Identifier: NCT00297687
Recruitment Status : Completed
First Posted : February 28, 2006
Last Update Posted : December 5, 2007
Information provided by:

Study Description
Brief Summary:
To determine the safety & immunogenicity of a potential vaccine against meningococcal B disease

Condition or disease Intervention/treatment Phase
Meningitis, Meningococcal Biological: MnB rLP2086 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Local & systemic safety throughout the trial

Secondary Outcome Measures :
  1. Evidence of an immune response 1 month after dose 2 & 1 month after dose 3

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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, medinfo@wyeth.com
More Information

ClinicalTrials.gov Identifier: NCT00297687     History of Changes
Other Study ID Numbers: 6108A1-500
First Posted: February 28, 2006    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007

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 Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs