Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00387725
First received: October 11, 2006
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents


Condition Intervention Phase
Healthy
Biological: rLP2086
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 µg, 60 µg, and 200 µg of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years

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

Primary Outcome Measures:
  • Serum Bacteriocidal Activity [ Time Frame: 1 month post-dose 3 (month 7) ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: October 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
20ug Experimental
Biological: rLP2086
Vaccine administered at 0, 1, and 6 months
Experimental: Group 2
60ug Experimental
Biological: rLP2086
Vaccine administered at 0, 1, and 6 months
Experimental: Group 3
200ug Experimental
Biological: rLP2086
Vaccine administered at 0, 1, and 6 months
Active Comparator: Group 4
Active comparator
Biological: rLP2086
Vaccine administered at 0, 1, and 6 months

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Aged 8 to 14 years at the time of enrollment.
  • Healthy male or female subjects
  • Negative urine pregnancy test for female subjects

Exclusion Criteria

  • Prior vaccination with a meningococcal B vaccine
  • Prior 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: NCT00387725

Locations
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

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00387725     History of Changes
Other Study ID Numbers: 6108A1-501
Study First Received: October 11, 2006
Last Updated: February 20, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Adolescent
Meningococcal
Safety

ClinicalTrials.gov processed this record on September 18, 2014