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
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 April 16, 2014