A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

NCT01352793

Last updated date
Study Location
Accelovance,Inc.
Huntsville, Alabama, 35802, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

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[email protected]

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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
10-25 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy subjects aged 10 to 25 years.

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


- Previous vaccination with Hepatitis A virus vaccine


- Previous vaccination with investigational meningococcal B vaccine


- History of culture-proven N. meningitidis serogroup B disease


- Any neuroinflammatory or autoimmune condition


- Any immune defect that would prevent an effective response to the study vaccine

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Meningitis, MeningococcalA Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
NCT01352793
  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 A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
Official Title  ICMJE A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years
Brief Summary

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 ?g rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Meningitis, Meningococcal
Intervention  ICMJE
  • Biological: rLP2086 vaccine
    120 mcg, 3 doses, at month 0, 2, and 6.
  • Biological: control
    HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.
Study Arms  ICMJE
  • Experimental: rLP2086 vaccine
    rLP2086 vaccine
    Intervention: Biological: rLP2086 vaccine
  • control
    The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.
    Intervention: Biological: control
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: February 6, 2015)
5715
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2011)
7500
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects aged 10 to 25 years.

Exclusion Criteria:

  • Previous vaccination with Hepatitis A virus vaccine
  • Previous vaccination with investigational meningococcal B vaccine
  • History of culture-proven N. meningitidis serogroup B disease
  • Any neuroinflammatory or autoimmune condition
  • Any immune defect that would prevent an effective response to the study vaccine
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Chile,   Czech Republic,   Denmark,   Estonia,   Finland,   Germany,   Lithuania,   Poland,   Spain,   Sweden,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT01352793
Other Study ID Numbers  ICMJE B1971014
2009-015198-11 ( EudraCT Number )
6108A1-3003 ( 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 February 2015

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