Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
NCT00387725
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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Descriptive Information | ||||
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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 |
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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 | 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
Exclusion Criteria: Exclusion Criteria
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Sex/Gender ICMJE |
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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 |
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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 |