Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults

Back to Search
Print
Bookmark Trial

NCT03760146

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Accel Resarch Sites
Birmingham, Alabama, 35216, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

1. Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and older.

2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.

3. Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.

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


1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
planned receipt through study participation.


2. History of microbiologically proven invasive disease caused by S pneumoniae.


3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive
pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with
or without dialysis, clinically unstable cardiac disease, or any other disorder that,
in the investigator's opinion, excludes the subject from participating in the study.


4. Pregnant female subjects or breastfeeding female subjects.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Pneumococcal Disease20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
NCT04546425
  1. Brussels,
  2. Praha 6,
  3. Tallinn,
  4. Tallinn,
  5. Tallinn,
  6. Tartu,
  7. Helsinki,
  8. Bydgoszcz,
  9. Krakow,
  10. Krakow,
  11. Leczna,
  12. Lodz,
  13. Siemianowice Slaskie,
  14. Torun,
  15. Trzebnica,
  16. Warszawa,
  17. Wroclaw,
  18. Bratislava,
  19. Horne Srnie,
  20. Liptovská Osada,
  21. Edegem,
  22. Jindrichuv Hradec,
  23. Jindrichuv Hradec,
  24. Jindrichuv Hradec,
  25. Pardubice,
  26. Praha 3,
  27. Sezemice,
  28. Espoo,
  29. Helsinki,
  30. Järvenpää,
  31. Kokkola,
  32. Oulu,
  33. Pori,
  34. Seinajoki,
  35. Tampere,
  36. Turku,
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Pneumococcal Disease20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
NCT04530838
  1. Toyota-shi, Aichi
  2. Chiba-shi, Chiba
  3. Funabashi-city, Chiba
  4. Yotsukaido-shi, Chiba
  5. Fukui-shi, Fukui
  6. Fukuoka-City, Fukuoka
  7. Fukuoka-city, Fukuoka
  8. Iizuka, Fukuoka
  9. Gifu-city, Gifu
  10. Ebetsu Shi, Hokkaido
  11. Sapporo shi, Hokkaido
  12. Sapporo, Hokkaido
  13. Akashi-City, Hyōgo
  14. Kawasaki-shi, Kanagawa
  15. Kumamoto Shi, Kumamoto
  16. Kumamoto-shi, Kumamoto
  17. Nagano-shi, Nagano
  18. Ureshino-shi, Saga
  19. Hanyu-shi, Saitama
  20. Kumagaya-shi, Saitama
  21. Fuchu-city, Tokyo
  22. Setagaya-ku, Tokyo
  23. Setagaya-ku, Tokyo
  24. Setagaya-ku, Tokyo
  25. Shinjuku-ku, Tokyo
  26. Suginami-ku, Tokyo
  27. Kofu-city, Yamanashi
  28. Tsuru-shi, Yamanashi
ALL GENDERS
2 Months+
years
MULTIPLE SITES
Pneumococcal DiseaseSafety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
NCT04526574
  1. Birmingham, Alabama
  2. Phoenix, Arizona
  3. Tempe, Arizona
  4. Redding, California
  5. San Diego, California
  6. Jacksonville, Florida
  7. Orlando, Florida
  8. Orlando, Florida
  9. Savannah, Georgia
  10. Stockbridge, Georgia
  11. Metairie, Louisiana
  12. Norfolk, Nebraska
  13. Endwell, New York
  14. Rocky Mount, North Carolina
  15. Rocky Mount, North Carolina
  16. Cedar Park, Texas
  17. Norfolk, Virginia
  18. Mobile, Alabama
  19. Chandler, Arizona
  20. Phoenix, Arizona
  21. San Diego, California
  22. Walnut Creek, California
  23. Coral Gables, Florida
  24. Crystal River, Florida
  25. Hialeah, Florida
  26. Miami, Florida
  27. Miami, Florida
  28. Meridian, Idaho
  29. El Dorado, Kansas
  30. Wichita, Kansas
  31. Wichita, Kansas
  32. New Orleans, Louisiana
  33. Elkridge, Maryland
  34. Rockville, Maryland
  35. Saint Louis, Missouri
  36. Omaha, Nebraska
  37. Las Vegas, Nevada
  38. Las Vegas, Nevada
  39. Binghamton, New York
  40. Charlotte, North Carolina
  41. Greensboro, North Carolina
  42. Hickory, North Carolina
  43. Raleigh, North Carolina
  44. Raleigh, North Carolina
  45. Wilmington, North Carolina
  46. Fargo, North Dakota
  47. Cincinnati, Ohio
  48. Cincinnati, Ohio
  49. Cleveland, Ohio
  50. Franklin, Ohio
  51. Warwick, Rhode Island
  52. Little River, South Carolina
  53. Mount Pleasant, South Carolina
  54. Bristol, Tennessee
  55. Nashville, Tennessee
  56. Austin, Texas
  57. Fort Worth, Texas
  58. Fort Worth, Texas
  59. Houston, Texas
  60. McKinney, Texas
  61. Pearland, Texas
  62. San Antonio, Texas
  63. Tomball, Texas
  64. Tomball, Texas
  65. Draper, Utah
  66. Salt Lake City, Utah
  67. Salt Lake City, Utah
  68. South Jordan, Utah
  69. Richmond, Virginia
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Pneumococcal Disease20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
NCT04382326
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Nampa, Idaho
  4. Baltimore, Maryland
  5. Baltimore, Maryland
  6. Brooklyn, New York
  7. Bayamon,
  8. Bayamon,
  9. San Juan,
  10. Cullman, Alabama
  11. Dothan, Alabama
  12. Phoenix, Arizona
  13. Fayetteville, Arkansas
  14. Bell Gardens, California
  15. Bellflower, California
  16. Covina, California
  17. Gardena, California
  18. Hawthorne, California
  19. Ontario, California
  20. Paramount, California
  21. Valencia, California
  22. West Covina, California
  23. Colorado Springs, Colorado
  24. Apopka, Florida
  25. Boynton Beach, Florida
  26. Gainesville, Florida
  27. Gainesville, Florida
  28. Hialeah, Florida
  29. Homestead, Florida
  30. Loxahatchee Groves, Florida
  31. Miami Lakes, Florida
  32. Miami, Florida
  33. Miami, Florida
  34. Tampa, Florida
  35. Chamblee, Georgia
  36. College Park, Georgia
  37. Columbus, Georgia
  38. Columbus, Georgia
  39. Ammon, Idaho
  40. Idaho Falls, Idaho
  41. Idaho Falls, Idaho
  42. Idaho Falls, Idaho
  43. Idaho Falls, Idaho
  44. Idaho Falls, Idaho
  45. Nampa, Idaho
  46. Ankeny, Iowa
  47. Des Moines, Iowa
  48. Des Moines, Iowa
  49. West Des Moines, Iowa
  50. El Dorado, Kansas
  51. Bardstown, Kentucky
  52. Louisville, Kentucky
  53. Baton Rouge, Louisiana
  54. Covington, Louisiana
  55. Haughton, Louisiana
  56. Metairie, Louisiana
  57. Baltimore, Maryland
  58. Frederick, Maryland
  59. Gulfport, Mississippi
  60. Missoula, Montana
  61. Lincoln, Nebraska
  62. Lincoln, Nebraska
  63. Albuquerque, New Mexico
  64. East Setauket, New York
  65. East Setauket, New York
  66. East Syracuse, New York
  67. Jackson Heights, New York
  68. Liverpool, New York
  69. Stony Brook, New York
  70. Stony Brook, New York
  71. Dayton, Ohio
  72. Dayton, Ohio
  73. Fairfield, Ohio
  74. South Euclid, Ohio
  75. East Norriton, Pennsylvania
  76. Erie, Pennsylvania
  77. Fort Washington, Pennsylvania
  78. Charleston, South Carolina
  79. Cheraw, South Carolina
  80. North Charleston, South Carolina
  81. Bristol, Tennessee
  82. Clarksville, Tennessee
  83. Kingsport, Tennessee
  84. Beaumont, Texas
  85. Beaumont, Texas
  86. Corpus Christi, Texas
  87. Houston, Texas
  88. Houston, Texas
  89. Longview, Texas
  90. McAllen, Texas
  91. McAllen, Texas
  92. San Antonio, Texas
  93. Kaysville, Utah
  94. Layton, Utah
  95. Murray, Utah
  96. Roy, Utah
  97. Saint George, Utah
  98. Syracuse, Utah
  99. Charlottesville, Virginia
  100. Charlottesville, Virginia
  101. Vancouver, Washington
  102. Guayama,
  103. Trujillo Alto,
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 YEARS OF AGE AND OLDER
Brief Summary A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Disease
Intervention  ICMJE
  • Biological: 20vPnC
    20vPnC
  • Biological: 13vPnC
    Pneumococcal conjugate vaccine
  • Biological: PPSV23
    Pneumococcal polysaccharide vaccine
    Other Name: Pneumovax 23
  • Other: Saline
    Placebo
Study Arms  ICMJE
  • Experimental: 60 years and above 20vPnC/Saline
    20vPnC and saline
    Interventions:
    • Biological: 20vPnC
    • Other: Saline
  • Active Comparator: 60 years and above 13vPnC/PPSV23
    13vPnC and PPSV23
    Interventions:
    • Biological: 13vPnC
    • Biological: PPSV23
  • Experimental: 50 through 59 years of age 20vPnC
    20vPnC
    Intervention: Biological: 20vPnC
  • Experimental: 18 through 49 years of age 20vPnC
    20vPnC
    Intervention: Biological: 20vPnC
  • Active Comparator: 50 through 59 years of age 13vPnC
    13vPnC
    Intervention: Biological: 13vPnC
  • Active Comparator: 18 through 49 years of age 13vPnC
    13vPnC
    Intervention: Biological: 13vPnC
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 11, 2020)		3902
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2018)		3880
Actual Study Completion Date  ICMJE December 16, 2019
Actual Primary Completion Date December 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and older.
  2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
  3. Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.

Exclusion Criteria:

  1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
  2. History of microbiologically proven invasive disease caused by S pneumoniae.
  3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
  4. Pregnant female subjects or breastfeeding female subjects.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03760146
Other Study ID Numbers  ICMJE B7471007
2018-004279-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
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 May 2020

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