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
medical corporation Shigyo-no-kai Sotobo Children's Clinic
Isumi-city, Chiba, 299-4503, 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
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

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 DiseaseSafety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
NCT04642079
  1. Bristol, Tennessee
  2. Jonesboro, Arkansas
  3. Jonesboro, Arkansas
  4. Inglewood, California
  5. San Diego, California
  6. Miami, Florida
  7. Miami, Florida
  8. Chamblee, Georgia
  9. Sioux City, Iowa
  10. Newton, Kansas
  11. Wichita, Kansas
  12. Bardstown, Kentucky
  13. Lexington, Kentucky
  14. Gulfport, Mississippi
  15. Grand Island, Nebraska
  16. Lincoln, Nebraska
  17. Lincoln, Nebraska
  18. Norfolk, Nebraska
  19. Omaha, Nebraska
  20. Henderson, Nevada
  21. Albuquerque, New Mexico
  22. Binghamton, New York
  23. Dayton, Ohio
  24. Dayton, Ohio
  25. Dayton, Ohio
  26. Medford, Oregon
  27. North Charleston, South Carolina
  28. Bristol, Tennessee
  29. Austin, Texas
  30. Galveston, Texas
  31. San Antonio, Texas
  32. Murray, Utah
  33. Provo, Utah
  34. Salt Lake City, Utah
  35. Salt Lake City, Utah
  36. Salt Lake City, Utah
  37. South Jordan, Utah
  38. Syracuse, Utah
  39. Charlottesville, Virginia
  40. Charlottesville, Virginia
ALL GENDERS
15 Months+
years
MULTIPLE SITES
Pneumococcal Disease20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
NCT04546425
  1. Nedlands, Western Australia
  2. Hvidovre,
  3. Roma, Rome
  4. Stavanger,
  5. Poznan,
  6. Poznan,
  7. Westmead, New South Wales
  8. Nedlands, Western Australia
  9. Brussels,
  10. Edegem,
  11. Jindrichuv Hradec,
  12. Jindrichuv Hradec,
  13. Jindrichuv Hradec,
  14. Pardubice,
  15. Praha 3,
  16. Praha 6,
  17. Sezemice,
  18. Tallinn,
  19. Tallinn,
  20. Tallinn,
  21. Tallinn,
  22. Tartu,
  23. Espoo,
  24. Helsinki,
  25. Helsinki,
  26. Järvenpää,
  27. Kokkola,
  28. Oulu,
  29. Pori,
  30. Seinajoki,
  31. Tampere,
  32. Turku,
  33. Milano, Milan
  34. Firenze,
  35. Foggia,
  36. Genova,
  37. Haarlem,
  38. Hoofddorp,
  39. Lorenskog,
  40. Oslo,
  41. Viken,
  42. Bydgoszcz,
  43. Bydgoszcz,
  44. Debica,
  45. Krakow,
  46. Krakow,
  47. Leczna,
  48. Lodz,
  49. Lubon,
  50. Siemianowice Slaskie,
  51. Torun,
  52. Trzebnica,
  53. Warszawa,
  54. Warszawa,
  55. Wroclaw,
  56. Wroclaw,
  57. Bratislava,
  58. Bratislava,
  59. Detva,
  60. Horne Srnie,
  61. Humenne,
  62. Humenné,
  63. Kosice,
  64. Liptovská Osada,
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Pneumococcal Disease20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
NCT04530838
  1. Isumi-city, Chiba
  2. Fukuoka-city, Fukuoka
  3. Fukuoka-shi, Fukuoka
  4. Osaka-City, Osaka
  5. Ritto-Shi, Shiga
  6. Nagoya-shi, Aichi
  7. Toyota-shi, Aichi
  8. Chiba-shi, Chiba
  9. Funabashi-city, Chiba
  10. Yotsukaido-shi, Chiba
  11. Yotsukaido-shi, Chiba
  12. Fukui-shi, Fukui
  13. Fukuoka-City, Fukuoka
  14. Fukuoka-city, Fukuoka
  15. Iizuka, Fukuoka
  16. Kasuga-city, Fukuoka
  17. Gifu-city, Gifu
  18. Ebetsu Shi, Hokkaido
  19. Sapporo shi, Hokkaido
  20. Sapporo, Hokkaido
  21. Akashi-City, Hyōgo
  22. Kawasaki-shi, Kanagawa
  23. Kumamoto Shi, Kumamoto
  24. Kumamoto-shi, Kumamoto
  25. Kuwana-city, MIE
  26. Nagano-shi, Nagano
  27. Kawachinagano, Osaka
  28. Ureshino-shi, Saga
  29. Hanyu-shi, Saitama
  30. Kumagaya-shi, Saitama
  31. Fuchu-city, Tokyo
  32. Nishitokyo-shi, Tokyo
  33. Setagaya-ku, Tokyo
  34. Setagaya-ku, Tokyo
  35. Shinjuku-ku, Tokyo
  36. Suginami-ku, Tokyo
  37. Kofu-city, Yamanashi
  38. 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. Miami Lakes, Florida
  2. Miami, Florida
  3. Wilmington, North Carolina
  4. Oklahoma City, Oklahoma
  5. Wauwatosa, Wisconsin
  6. Birmingham, Alabama
  7. Mobile, Alabama
  8. Chandler, Arizona
  9. Phoenix, Arizona
  10. Tempe, Arizona
  11. Redding, California
  12. San Diego, California
  13. San Diego, California
  14. Walnut Creek, California
  15. Coral Gables, Florida
  16. Crystal River, Florida
  17. Hialeah, Florida
  18. Jacksonville, Florida
  19. Miami, Florida
  20. Orlando, Florida
  21. Orlando, Florida
  22. Savannah, Georgia
  23. Stockbridge, Georgia
  24. Meridian, Idaho
  25. El Dorado, Kansas
  26. Wichita, Kansas
  27. Wichita, Kansas
  28. Metairie, Louisiana
  29. New Orleans, Louisiana
  30. Elkridge, Maryland
  31. Rockville, Maryland
  32. Saint Louis, Missouri
  33. Norfolk, Nebraska
  34. Omaha, Nebraska
  35. Las Vegas, Nevada
  36. Las Vegas, Nevada
  37. Binghamton, New York
  38. Endwell, New York
  39. Charlotte, North Carolina
  40. Greensboro, North Carolina
  41. Hickory, North Carolina
  42. Raleigh, North Carolina
  43. Raleigh, North Carolina
  44. Rocky Mount, North Carolina
  45. Rocky Mount, 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. Cedar Park, Texas
  58. Fort Worth, Texas
  59. Fort Worth, Texas
  60. Houston, Texas
  61. McKinney, Texas
  62. Pearland, Texas
  63. San Antonio, Texas
  64. Tomball, Texas
  65. Tomball, Texas
  66. Draper, Utah
  67. Salt Lake City, Utah
  68. Salt Lake City, Utah
  69. South Jordan, Utah
  70. Norfolk, Virginia
  71. Richmond, Virginia
ALL GENDERS
65 Years+
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 1, 2021)		668
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2020)		666
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 information is only displayed when the study is recruiting subjects
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 April 2021

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