Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects

NCT00500266

Last updated date
Study Location
Chandler, Arizona, 85224, 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
68 + years

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 Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
Official Title  ICMJE A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, & Reactogenicity of a 13vPnC Vaccine in Ambulatory Elderly Adults Aged 68 Years & Older Who Received 1 or More Doses of 23vPS Vaccine at Least 3 Years Before Study Enrollment
Brief Summary To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vPS) at least 3 years before study enrollment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
Study Arms  ICMJE Experimental: 1
13-valent Pneumococcal Conjugate Vaccine
Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine (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: July 10, 2007)
1053
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

MAIN INCLUSION CRITERIA:

  • Male or female aged 68 years or older
  • Determined by medical history, physical examination, and clinical judgment to be eligible for the study
  • Documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years before study enrollment

MAIN EXCLUSION CRITERIA:

  • Known history of severe reaction to a vaccine
  • Documented S pneumoniae infection within the past 5 years.
  • Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids
  • Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease 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 precludes the subject from participating in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 68 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 Germany,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00500266
Other Study ID Numbers  ICMJE 6115A1-3000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date August 2011

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