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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00297687
First received: February 24, 2006
Last updated: December 3, 2007
Last verified: December 2007
  Purpose

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
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297687

Locations
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
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia, medinfo@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov 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:
Vaccines
Healthy Adults
Health
Adult
Meningococcal Vaccines

Additional relevant MeSH terms:
Meningitis
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

ClinicalTrials.gov processed this record on October 02, 2014