Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults

NCT00297687

Last updated date
Study Location
Herson, Queensland, 4006, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningitis, Meningococcal
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-25 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy 18-25 year olds

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


- Prior history of vaccination with any meningococcal vaccine


- Prior history of any invasive meningococcal disease

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  1. Huntsville, Alabama
  2. Chandler, Arizona
  3. Chandler, Arizona
  4. Tempe, Arizona
  5. Tempe, Arizona
  6. Tempe, Arizona
  7. Harrisburg, Arkansas
  8. San Diego, California
  9. San Francisco, California
  10. Vista, California
  11. DeLand, Florida
  12. Jacksonville, Florida
  13. Melbourne, Florida
  14. Melbourne, Florida
  15. South Miami, Florida
  16. Mishawaka, Indiana
  17. Council Bluffs, Iowa
  18. Bardstown, Kentucky
  19. Fremont, Nebraska
  20. Fremont, Nebraska
  21. Rochester, New York
  22. Cleveland, Ohio
  23. Dayton, Ohio
  24. Mt. Pleasant, South Carolina
  25. Bristol, Tennessee
  26. Austin, Texas
  27. Austin, Texas
  28. Dallas, Texas
  29. Fort Worth, Texas
  30. Houston, Texas
  31. Katy, Texas
  32. San Antonio, Texas
  33. Salt Lake City, Utah
  34. Salt Lake City, Utah
  35. Salt Lake City, Utah
  36. South Jordan, Utah
  37. West Jordan, Utah
  38. Burke, Virginia
  39. Charlottesville, Virginia
  40. Maroubra, New South Wales
  41. Westmead, New South Wales
  42. Sherwood, Queensland
  43. North Adelaide, South Australia
  44. Subiaco,
  45. Temuco, Araucania
  46. Santiago, Region Metropolitana
  47. Santiago, Region Metropolitana
  48. Conchali, Santiago
  49. Santiago,
  50. Jindrichuv Hradec,
  51. Jindrichuv Hradec,
  52. Jindrichuv Hradec,
  53. Plzen,
  54. Praha 2,
  55. Tynec nad Sazavou,
  56. Aarhus N,
  57. Rakvere,
  58. Tallinn,
  59. Tallinn,
  60. Tallinn,
  61. Pori,
  62. Tampere,
  63. Turku,
  64. Hamburg,
  65. Hamburg,
  66. Hamburg,
  67. Wuerzburg,
  68. Kaunas,
  69. Kaunas,
  70. Kaunas,
  71. Kaunas,
  72. Vilnius,
  73. Debica,
  74. Krakow,
  75. Krakow,
  76. Lubartow,
  77. Oborniki Slaskie,
  78. Poznan,
  79. Siemianowice Slaskie,
  80. Torun,
  81. Trzebnica,
  82. Wroclaw,
  83. Sevilla,
  84. Valencia,
  85. Malmo, SE
  86. Umeå,
ALL GENDERS
10 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
Official Title  ICMJE A Randomized, Placebo-Controlled, Double Blind, Phase 1 Trial of the Safety, Immunogenicity, and Tolerability of Ascending Doses of Meningococcal Group B rLP2086 Vaccine in Healthy Adults
Brief Summary To determine the safety & immunogenicity of a potential vaccine against meningococcal B disease
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Meningitis, Meningococcal
Intervention  ICMJE Biological: MnB rLP2086
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: February 27, 2006)
108
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy 18-25 year olds

Exclusion Criteria:

  • Prior history of vaccination with any meningococcal vaccine
  • Prior history of any invasive meningococcal disease
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00297687
Other Study ID Numbers  ICMJE 6108A1-500
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Australia, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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