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Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

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NCT00387725

Last updated on August 9, 2018
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FOR MORE INFORMATION
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

NCT00387725
Pfizer
Completed
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

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Pfizer Clinical Trials Contact Center

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[email protected]

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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 (Participant, 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
Sexes Eligible for Study: All
8 Years to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00387725
6108A1-501
B1971006 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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