A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age

NCT01461980

Last updated date
Study Location
Radiant Research, Inc.
Birmingham, Alabama, 35209, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaccines, Meningococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-12 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study.

- Parent /legally authorized representative and subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.

- Male or female subject aged greater than or equal to 10 and <13 years at the time of enrollment.

- Available for the entire study period and can be reached by telephone.

- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

- Has received full series (5-dose series is preferred, 4-dose catch up series is allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per country specific recommendations applicable at the time of receipt.

- Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study.

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


- Previous vaccination with any meningococcal serogroup B vaccine.


- Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the
first study vaccination.


- Previous vaccination with any MCV4 vaccine.


- A previous anaphylactic reaction to any vaccine or vaccine-related component.


- Contraindication to vaccination with MCV4 and/or Tdap vaccine.


- Subjects receiving any allergen immunotherapy with a non-licensed product or receiving
allergen immunotherapy with a licensed product and are not on stable maintenance
doses.


- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.


- A known or suspected defect of the immune system that would prevent an immune response
to the vaccine, such as subjects with congenital or acquired defects in B cell
function, those receiving chronic systemic (oral, intravenous or intramuscular)
corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with
terminal complement deficiency may not be included.


- History of culture-proven disease caused by Neisseria meningitidis or Neisseria
gonorrhoea.


- Significant neurological disorder or history of seizure (excluding simple febrile
seizure).


- Receipt of any blood products, including immunoglobulin within 6 months before the
first study vaccination.


- Current chronic use of systemic antibiotics.


- Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

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Pfizer Clinical Trials Contact Center

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Vaccines, Meningococcal VaccinesA Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
NCT01461980
  1. Birmingham, Alabama
  2. Daphne, Alabama
  3. Chandler, Arizona
  4. Chandler, Arizona
  5. Mesa, Arizona
  6. Mesa, Arizona
  7. Tucson, Arizona
  8. Tucson, Arizona
  9. Jonesboro, Arkansas
  10. Little Rock, Arkansas
  11. Fresno, California
  12. Hayward, California
  13. Huntington Beach, California
  14. Loma Linda, California
  15. Loma Linda, California
  16. Loma Linda, California
  17. Moreno Valley, California
  18. Paramount, California
  19. Paramount, California
  20. Sacramento, California
  21. San Diego, California
  22. Valley Village, California
  23. Colorado Springs, Colorado
  24. Colorado Springs, Colorado
  25. Denver, Colorado
  26. Norwich, Connecticut
  27. Tampa, Florida
  28. Atlanta, Georgia
  29. Atlanta, Georgia
  30. Atlanta, Georgia
  31. Dalton, Georgia
  32. Marietta, Georgia
  33. Woodstock, Georgia
  34. Meridian, Idaho
  35. DeKalb, Illinois
  36. Council Bluffs, Iowa
  37. Augusta, Kansas
  38. Wichita, Kansas
  39. Wichita, Kansas
  40. Bardstown, Kentucky
  41. Louisville, Kentucky
  42. Louisville, Kentucky
  43. Louisville, Kentucky
  44. Stevensville, Michigan
  45. Saint Paul, Minnesota
  46. Saint Paul, Minnesota
  47. Saint Paul, Minnesota
  48. Kansas City, Missouri
  49. Saint Louis, Missouri
  50. Saint Louis, Missouri
  51. Saint Louis, Missouri
  52. Saint Louis, Missouri
  53. Fremont, Nebraska
  54. Lincoln, Nebraska
  55. Omaha, Nebraska
  56. Omaha, Nebraska
  57. Henderson, Nevada
  58. Las Vegas, Nevada
  59. East Syracuse, New York
  60. Durham, North Carolina
  61. Durham, North Carolina
  62. Durham, North Carolina
  63. Raleigh, North Carolina
  64. Raleigh, North Carolina
  65. Raleigh, North Carolina
  66. Fargo, North Dakota
  67. Fargo, North Dakota
  68. Akron, Ohio
  69. Cincinnati, Ohio
  70. Cincinnati, Ohio
  71. Cleveland, Ohio
  72. Cleveland, Ohio
  73. Cleveland, Ohio
  74. Columbus, Ohio
  75. Dayton, Ohio
  76. Dayton, Ohio
  77. Huber Heights, Ohio
  78. Kettering, Ohio
  79. El Reno, Oklahoma
  80. Norman, Oklahoma
  81. Oklahoma City, Oklahoma
  82. Tulsa, Oklahoma
  83. Cranston, Rhode Island
  84. Warwick, Rhode Island
  85. Anderson, South Carolina
  86. Charleston, South Carolina
  87. Mount Pleasant, South Carolina
  88. Bristol, Tennessee
  89. Bristol, Tennessee
  90. Nashville, Tennessee
  91. Austin, Texas
  92. Dallas, Texas
  93. Houston, Texas
  94. Houston, Texas
  95. Houston, Texas
  96. Houston, Texas
  97. Houston, Texas
  98. San Antonio, Texas
  99. San Antonio, Texas
  100. San Antonio, Texas
  101. San Antonio, Texas
  102. Tomball, Texas
  103. Tomball, Texas
  104. Murray, Utah
  105. Salt Lake City, Utah
  106. Salt Lake City, Utah
  107. Salt Lake City, Utah
  108. South Jordan, Utah
  109. West Jordan, Utah
  110. Burke, Virginia
  111. Charlottesville, Virginia
  112. Charlottesville, Virginia
  113. Charlottesville, Virginia
  114. Vancouver, Washington
  115. Vancouver, Washington
  116. La Crosse, Wisconsin
  117. Monroe, Wisconsin
ALL GENDERS
10 Years+
years
MULTIPLE SITES
Vaccines, Meningococcal VaccinesA Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17
NCT01461993
  1. Daphne, Alabama
  2. Chandler, Arizona
  3. Jonesboro, Arkansas
  4. Little Rock, Arkansas
  5. Cypress, California
  6. Huntington Beach, California
  7. Moreno Valley, California
  8. Paramount, California
  9. Paramount, California
  10. San Diego, California
  11. Valley Village, California
  12. Colorado Springs, Colorado
  13. Colorado Springs, Colorado
  14. Miami, Florida
  15. Marietta, Georgia
  16. Stockbridge, Georgia
  17. Woodstock, Georgia
  18. Meridian, Idaho
  19. Indianapolis, Indiana
  20. Wichita, Kansas
  21. Bardstown, Kentucky
  22. Lexington, Kentucky
  23. Louisville, Kentucky
  24. Louisville, Kentucky
  25. Saint Paul, Minnesota
  26. Saint Paul, Minnesota
  27. Kansas City, Missouri
  28. Saint Louis, Missouri
  29. Saint Louis, Missouri
  30. Saint Louis, Missouri
  31. Lincoln, Nebraska
  32. Omaha, Nebraska
  33. Henderson, Nevada
  34. Henderson, Nevada
  35. Las Vegas, Nevada
  36. Rochester, New York
  37. Rochester, New York
  38. Syracuse, New York
  39. Cary, North Carolina
  40. Durham, North Carolina
  41. Durham, North Carolina
  42. Durham, North Carolina
  43. Raleigh, North Carolina
  44. Raleigh, North Carolina
  45. Raleigh, North Carolina
  46. Raleigh, North Carolina
  47. Fargo, North Dakota
  48. Cincinnati, Ohio
  49. Cincinnati, Ohio
  50. Cleveland, Ohio
  51. Cleveland, Ohio
  52. Norman, Oklahoma
  53. Oklahoma City, Oklahoma
  54. Tulsa, Oklahoma
  55. Tulsa, Oklahoma
  56. Carnegie, Pennsylvania
  57. Erie, Pennsylvania
  58. Sellersville, Pennsylvania
  59. Cranston, Rhode Island
  60. Warwick, Rhode Island
  61. Charleston, South Carolina
  62. Mount Pleasant, South Carolina
  63. Mount Pleasant, South Carolina
  64. Nashville, Tennessee
  65. Austin, Texas
  66. Austin, Texas
  67. Houston, Texas
  68. Houston, Texas
  69. Houston, Texas
  70. League City, Texas
  71. San Angelo, Texas
  72. San Antonio, Texas
  73. San Antonio, Texas
  74. San Antonio, Texas
  75. San Antonio, Texas
  76. Tomball, Texas
  77. Tomball, Texas
  78. Murray, Utah
  79. Salt Lake City, Utah
  80. Charlottesville, Virginia
  81. Charlottesville, Virginia
  82. Charlottesville, Virginia
  83. Norfolk, Virginia
  84. Vienna, Virginia
  85. Vancouver, Washington
  86. Vancouver, Washington
  87. Monroe, Wisconsin
ALL GENDERS
11 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
Official Title  ICMJE A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Mcv4, Tdap Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged > = 10 To <13 Years
Brief Summary This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Vaccines
  • Meningococcal Vaccines
Intervention  ICMJE
  • Biological: rLP2086 + MCV4 + Tdap
    At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.
  • Biological: MCV4 + Tdap + saline
    At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only.
  • Biological: rLP2086 + saline
    At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6).
Study Arms  ICMJE
  • Active Comparator: MCV4 + Tdap+ rLP2086
    Group 1 - MCV4 + Tdap + rLP2086
    Intervention: Biological: rLP2086 + MCV4 + Tdap
  • Active Comparator: MCV4 + Tdap + saline
    Group 2, MCV4 + Tdap+ saline
    Intervention: Biological: MCV4 + Tdap + saline
  • Placebo Comparator: Saline + saline + rLP2086
    Group 3- rLP2086 + saline
    Intervention: Biological: rLP2086 + saline
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: May 7, 2015)
2648
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2011)
2625
Actual Study Completion Date  ICMJE May 8, 2014
Actual Primary Completion Date May 8, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study.
  • Parent /legally authorized representative and subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
  • Male or female subject aged greater than or equal to 10 and <13 years at the time of enrollment.
  • Available for the entire study period and can be reached by telephone.
  • Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
  • Has received full series (5-dose series is preferred, 4-dose catch up series is allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per country specific recommendations applicable at the time of receipt.
  • Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study.

Exclusion Criteria:

  • Previous vaccination with any meningococcal serogroup B vaccine.
  • Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the first study vaccination.
  • Previous vaccination with any MCV4 vaccine.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with MCV4 and/or Tdap vaccine.
  • Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may not be included.
  • History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea.
  • Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  • Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
  • Current chronic use of systemic antibiotics.
  • Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461980
Other Study ID Numbers  ICMJE B1971015
6108A1-2005 ( 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 2018

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