20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

Back to Search
Print
Bookmark Trial

NCT04530838

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Fukazawa Clinic
Fukuoka-City, Fukuoka, 813-0036, Japan
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
2-6 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Japanese male or female infants ≥2 months to ≤6 months at the time of consent.

- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

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


- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis)


- Major known congenital malformation or serious chronic disorder.


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


- Other acute or chronic medical or psychiatric condition or laboratory abnormality that
may increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.

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. Espoo,
  2. Järvenpää,
  3. Oulu,
  4. Pori,
  5. Seinajoki,
  6. Turku,
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Pneumococcal Disease20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
NCT04530838
  1. Fukuoka-City, Fukuoka
  2. Akashi-City, Hyōgo
  3. Kumamoto-shi, Kumamoto
  4. Setagaya-ku, Tokyo
  5. Shinjuku-ku, Tokyo
  6. Suginami-ku, Tokyo
ALL GENDERS
2 Months+
years
MULTIPLE SITES
Pneumococcal DiseaseSafety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
NCT04526574
  1. Mobile, Alabama
  2. Chandler, Arizona
  3. Phoenix, Arizona
  4. San Diego, California
  5. Coral Gables, Florida
  6. Hialeah, Florida
  7. Miami, Florida
  8. Wichita, Kansas
  9. Elkridge, Maryland
  10. Rockville, Maryland
  11. Omaha, Nebraska
  12. Charlotte, North Carolina
  13. Greensboro, North Carolina
  14. Hickory, North Carolina
  15. Raleigh, North Carolina
  16. Wilmington, North Carolina
  17. Fargo, North Dakota
  18. Cincinnati, Ohio
  19. Cincinnati, Ohio
  20. Franklin, Ohio
  21. Warwick, Rhode Island
  22. Little River, South Carolina
  23. Mount Pleasant, South Carolina
  24. Bristol, Tennessee
  25. Nashville, Tennessee
  26. Austin, Texas
  27. Fort Worth, Texas
  28. Fort Worth, Texas
  29. Houston, Texas
  30. McKinney, Texas
  31. Pearland, Texas
  32. San Antonio, Texas
  33. Tomball, Texas
  34. Tomball, Texas
  35. Draper, Utah
  36. Salt Lake City, Utah
  37. Salt Lake City, Utah
  38. South Jordan, Utah
  39. 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. Covina, California
  2. West Covina, California
  3. Lake Mary, Florida
  4. Loxahatchee Groves, Florida
  5. Baltimore, Maryland
  6. Frederick, Maryland
  7. East Setauket, New York
  8. East Setauket, New York
  9. Stony Brook, New York
  10. Stony Brook, New York
  11. Houston, Texas
  12. Cullman, Alabama
  13. Dothan, Alabama
  14. Phoenix, Arizona
  15. Fayetteville, Arkansas
  16. Bell Gardens, California
  17. Bellflower, California
  18. Gardena, California
  19. Hawthorne, California
  20. Los Angeles, California
  21. Ontario, California
  22. Paramount, California
  23. Valencia, California
  24. Colorado Springs, Colorado
  25. Apopka, Florida
  26. Boynton Beach, Florida
  27. Gainesville, Florida
  28. Gainesville, Florida
  29. Hialeah, Florida
  30. Homestead, Florida
  31. Miami Lakes, Florida
  32. Miami, Florida
  33. Miami, Florida
  34. Tampa, Florida
  35. Chamblee, Georgia
  36. Columbus, Georgia
  37. Columbus, Georgia
  38. Ammon, Idaho
  39. Idaho Falls, Idaho
  40. Idaho Falls, Idaho
  41. Idaho Falls, Idaho
  42. Idaho Falls, Idaho
  43. Idaho Falls, Idaho
  44. Nampa, Idaho
  45. Ankeny, Iowa
  46. Des Moines, Iowa
  47. Des Moines, Iowa
  48. West Des Moines, Iowa
  49. El Dorado, Kansas
  50. Bardstown, Kentucky
  51. Louisville, Kentucky
  52. Baton Rouge, Louisiana
  53. Covington, Louisiana
  54. Haughton, Louisiana
  55. Metairie, Louisiana
  56. Gulfport, Mississippi
  57. Missoula, Montana
  58. Lincoln, Nebraska
  59. Lincoln, Nebraska
  60. Albuquerque, New Mexico
  61. East Syracuse, New York
  62. Liverpool, New York
  63. Dayton, Ohio
  64. Dayton, Ohio
  65. Fairfield, Ohio
  66. South Euclid, Ohio
  67. East Norriton, Pennsylvania
  68. Erie, Pennsylvania
  69. Fort Washington, Pennsylvania
  70. Charleston, South Carolina
  71. Cheraw, South Carolina
  72. North Charleston, South Carolina
  73. Bristol, Tennessee
  74. Clarksville, Tennessee
  75. Kingsport, Tennessee
  76. Corpus Christi, Texas
  77. Houston, Texas
  78. Longview, Texas
  79. McAllen, Texas
  80. San Antonio, Texas
  81. Kaysville, Utah
  82. Layton, Utah
  83. Murray, Utah
  84. Roy, Utah
  85. Saint George, Utah
  86. Syracuse, Utah
  87. Charlottesville, Virginia
  88. Charlottesville, Virginia
  89. Vancouver, Washington
  90. Guayama,
  91. Trujillo Alto,
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY UNBLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY JAPANESE INFANTS
Brief Summary 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
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 Pneumococcal Disease
Intervention  ICMJE
  • Biological: 20-valent pneumococcal conjugate vaccine
    20-valent pneumococcal conjugate vaccine
  • Biological: 13-valent pneumococcal conjugate vaccine
    13-valent pneumococcal conjugate vaccine
Study Arms  ICMJE
  • Experimental: 20-valent pneumococcal conjugate vaccine (subcutaneous)
    20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
    Intervention: Biological: 20-valent pneumococcal conjugate vaccine
  • Active Comparator: 13-valent pneumococcal conjugate vaccine (subcutaneous)
    13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Experimental: 20-valent pneumococcal conjugate vaccine (intramuscular)
    20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)
    Intervention: Biological: 20-valent pneumococcal conjugate vaccine
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 25, 2020)		666
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 21, 2022
Estimated Primary Completion Date April 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese male or female infants ?2 months to ?6 months at the time of consent.
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
  • Major known congenital malformation or serious chronic disorder.
  • History of microbiologically proven invasive disease caused by S pneumoniae.
  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Months to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04530838
Other Study ID Numbers  ICMJE B7471016
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
Product Manufactured in and Exported from the U.S.: Yes
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 September 2020

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