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

October 11, 2006
February 20, 2013
October 2006
January 2008   (final data collection date for primary outcome measure)
Serum Bacteriocidal Activity [ Time Frame: 1 month post-dose 3 (month 7) ] [ Designated as safety issue: No ]
Serum Bacteriocidal Activity
Complete list of historical versions of study NCT00387725 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
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

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy
Biological: rLP2086
Vaccine administered at 0, 1, and 6 months
  • Experimental: Group A
    20ug Experimental
    Intervention: Biological: rLP2086
  • Experimental: Group 2
    60ug Experimental
    Intervention: Biological: rLP2086
  • Experimental: Group 3
    200ug Experimental
    Intervention: Biological: rLP2086
  • Active Comparator: Group 4
    Active comparator
    Intervention: Biological: rLP2086
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
8 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00387725
6108A1-501
Yes
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia, medinfo@wyeth.com
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP