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Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00387725
First received: October 11, 2006
Last updated: November 14, 2014
Last verified: November 2014

October 11, 2006
November 14, 2014
November 2006
January 2008   (final data collection date for primary outcome measure)
  • Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 [ Time Frame: 1 month after Dose 2 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 [ Time Frame: 1 month after Dose 3 ] [ Designated as safety issue: No ]
  • Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Dose 1 up to 1 month after Dose 3 ] [ Designated as safety issue: Yes ]
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 ½ Trial Of The Safety, Immunogenicity, And Tolerability Of 20 Mg, 60 Mg, And 200 Mg Of Meningococcal Group B Rlp2086 Vaccine In Healthy Children And Adolescents Aged 8 To 14 Years

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
February 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion 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:

Exclusion Criteria

  • Prior vaccination with a meningococcal B vaccine
  • Prior meningococcal disease
Both
8 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00387725
6108A1-501, B1971006
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2014

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