Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

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NCT00387725

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Study Location
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
8-14 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Exclusion Criteria


- Prior vaccination with a meningococcal B vaccine


- Prior meningococcal disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
Official Title  ICMJE 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
Brief Summary Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE Biological: rLP2086
Vaccine administered at 0, 1, and 6 months
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2007)		127
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 8 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00387725
Other Study ID Numbers  ICMJE 6108A1-501
B1971006 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2014

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