Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

NCT00546572

Last updated date
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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 Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
70 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or Female aged 70 years or older.

- Documented vaccination with 1 dose of 23vPS at least 5 years previous.

- Healthy.

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


- Receipt of more than one dose of 23vPS prior to enrollment.


- History of severe adverse reaction to a vaccine.


- Immunodeficiency.

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]

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.

Based on your search, you may also be interested in

Pneumococcal InfectionsStudy Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
NCT00452790
  1. Sector-12, Chandigarh
  2. Sector-32 B, Chandigarh
  3. Bangalore, Karnataka
  4. Bangalore, Karnataka
  5. Mumbai, Maharashtra
  6. Pune, Maharashtra
  7. Pune, Maharashtra
  8. Pune, Maharashtra
  9. Rajinder Nagar, New Delhi
  10. Ludhiana, Punjab
  11. Chennai, Tamil Nadu
  12. Vellore, Tamil Nadu
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Pneumococcal InfectionsStudy Investigating Administration of Prevenar for Post-Marketing Surveillance
NCT00195390
  1. Seoul,
ALL GENDERS
6 Weeks+
years
MULTIPLE SITES
Pneumococcal InfectionsStudy to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
NCT03550313
  1. Miami, Florida
  2. Houston, Texas
  3. Saint George, Utah
  4. Harrisburg, Arkansas
  5. Anaheim, California
  6. Downey, California
  7. Huntington Beach, California
  8. Madera, California
  9. Ontario, California
  10. Paramount, California
  11. San Diego, California
  12. Boynton Beach, Florida
  13. DeLand, Florida
  14. Homestead, Florida
  15. Miami Lakes, Florida
  16. Miami, Florida
  17. Miami, Florida
  18. Columbus, Georgia
  19. Park Ridge, Illinois
  20. Mishawaka, Indiana
  21. Louisville, Kentucky
  22. Nicholasville, Kentucky
  23. Baton Rouge, Louisiana
  24. Metairie, Louisiana
  25. Shreveport, Louisiana
  26. Shreveport, Louisiana
  27. Silver Spring, Maryland
  28. Boston, Massachusetts
  29. Kansas City, Missouri
  30. Omaha, Nebraska
  31. East Syracuse, New York
  32. Liverpool, New York
  33. Boone, North Carolina
  34. Winston-Salem, North Carolina
  35. Winston-Salem, North Carolina
  36. Dayton, Ohio
  37. Erie, Pennsylvania
  38. Charleston, South Carolina
  39. Greenville, South Carolina
  40. Sioux Falls, South Dakota
  41. Sioux Falls, South Dakota
  42. Sioux Falls, South Dakota
  43. Sioux Falls, South Dakota
  44. Sioux Falls, South Dakota
  45. Sioux Falls, South Dakota
  46. Kingsport, Tennessee
  47. Houston, Texas
  48. Houston, Texas
  49. Keller, Texas
  50. San Antonio, Texas
  51. Spring, Texas
  52. Spokane, Washington
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Pneumococcal InfectionsTrial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
NCT03512288
  1. Fayetteville, Arkansas
  2. Downey, California
  3. Huntington Beach, California
  4. Oakland, California
  5. Ontario, California
  6. Sacramento, California
  7. San Jose, California
  8. Santa Clara, California
  9. Haughton, Louisiana
  10. Metairie, Louisiana
  11. Shreveport, Louisiana
  12. Shreveport, Louisiana
  13. Omaha, Nebraska
  14. East Syracuse, New York
  15. Boone, North Carolina
  16. Raleigh, North Carolina
  17. Cincinnati, Ohio
  18. Cincinnati, Ohio
  19. Cincinnati, Ohio
  20. Cincinnati, Ohio
  21. Cincinnati, Ohio
  22. Dayton, Ohio
  23. South Euclid, Ohio
  24. Tulsa, Oklahoma
  25. Erie, Pennsylvania
  26. Hermitage, Pennsylvania
  27. Philadelphia, Pennsylvania
  28. Charleston, South Carolina
  29. Charleston, South Carolina
  30. North Charleston, South Carolina
  31. Galveston, Texas
  32. San Antonio, Texas
  33. Layton, Utah
  34. Murray, Utah
  35. Roy, Utah
  36. South Jordan, Utah
  37. Syracuse, Utah
  38. Charlottesville, Virginia
  39. Charlottesville, Virginia
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
Official Title  ICMJE A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Compared To A 23-Valent Pneumococcal Polysaccharide (23vPS) Vaccine in Ambulatory Elderly Individuals Aged 70 Years And Older Who Received One Dose of 23vPS At Least 5 Years Prior To Study Enrollment
Brief Summary This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.
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 Infections
Intervention  ICMJE
  • Biological: 13 valent Pneumococcal Conjugate Vaccine
    0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
  • Biological: 23vPS
    0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1
Study Arms  ICMJE
  • Experimental: 1
    Receives 13vPnC at year 0 and 13vPnC at year 1
    Intervention: Biological: 13 valent Pneumococcal Conjugate Vaccine
  • Active Comparator: 2
    Receives 23vPS at year 0 and 13vPnC at year 1
    Intervention: Biological: 23vPS
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 17, 2010)
938
Original Enrollment  ICMJE
 (submitted: October 18, 2007)
920
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female aged 70 years or older.
  • Documented vaccination with 1 dose of 23vPS at least 5 years previous.
  • Healthy.

Exclusion Criteria:

  • Receipt of more than one dose of 23vPS prior to enrollment.
  • History of severe adverse reaction to a vaccine.
  • Immunodeficiency.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 70 Years and older   (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 NCT00546572
Other Study ID Numbers  ICMJE 6115A1-3005
B1851024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2011

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