A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years

Back to Search
Print
Bookmark Trial

NCT02561195

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Avail Clinical Research, LLC
DeLand, Florida, 32720, 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.
Clostridium Difficile Associated Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and female subjects

- Aged 65 to 85 years

Additional Inclusion Criteria for the extension Stage:

- Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in the original portion of the study.

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


- Proven or suspected prior episode of Clostridium difficile associated diarrhea


- Unstable chronic medical condition


- Disease requiring significant change in therapy or hospitalization for worsening
disease within 8 weeks before receipt of study vaccine


- Serious chronic disorders


- Congenital or acquired immunodeficiency disorders


- Rheumatologic disorders or other illnesses requiring chronic treatment with known
immunosuppressant medications.


- Active or treated leukemia or lymphoma or bone marrow disorder


- Any contraindication to vaccination or vaccine components including previous
anaphylactic reaction to any vaccine or vaccine-related components


Additional Exclusion Criteria for the Extension Stage:


- Subjects originally randomized to placebo during the original portion of the study.


- Subjects who have already completed Visit 9 prior to study unblinding.

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

Clostridium Difficile Associated DiseaseEvaluation of a 3-dose Vaccination Regimen With One of Three Ascending Dose Levels of Clostridium Difficile Vaccine With or Without Adjuvant in Healthy Adults Aged 50 to 85 Years
NCT01706367
  1. Pembroke Pines, Florida
  2. South Miami, Florida
  3. Overland Park, Kansas
  4. Cary, North Carolina
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Clostridium Difficile Associated DiseaseClostridium Difficile Vaccine 2-Dose Versus 3-Dose Study
NCT03918629
  1. Phoenix, Arizona
  2. San Diego, California
  3. DeLand, Florida
  4. Raritan, New Jersey
  5. Fargo, North Dakota
  6. Little River, South Carolina
  7. Athens, Alabama
  8. Huntsville, Alabama
  9. Chandler, Arizona
  10. Peoria, Arizona
  11. Phoenix, Arizona
  12. Phoenix, Arizona
  13. Redding, California
  14. Wheat Ridge, Colorado
  15. Clearwater, Florida
  16. Miami, Florida
  17. Orlando, Florida
  18. Orlando, Florida
  19. Pembroke Pines, Florida
  20. Port Orange, Florida
  21. Savannah, Georgia
  22. Idaho Falls, Idaho
  23. Mishawaka, Indiana
  24. Metairie, Louisiana
  25. Biloxi, Mississippi
  26. Chesterfield, Missouri
  27. Rochester, New York
  28. Charlotte, North Carolina
  29. Greensboro, North Carolina
  30. Hickory, North Carolina
  31. Raleigh, North Carolina
  32. Wilmington, North Carolina
  33. Winston-Salem, North Carolina
  34. Columbus, Ohio
  35. Dayton, Ohio
  36. Goose Creek, South Carolina
  37. Mount Pleasant, South Carolina
  38. Bristol, Tennessee
  39. Austin, Texas
  40. Bellaire, Texas
  41. Fort Worth, Texas
  42. Fort Worth, Texas
  43. Houston, Texas
  44. San Antonio, Texas
  45. Tomball, Texas
  46. Tomball, Texas
  47. Draper, Utah
  48. Salt Lake City, Utah
  49. Salt Lake City, Utah
  50. South Jordan, Utah
  51. Midlothian, Virginia
  52. Wenatchee, Washington
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Clostridium Difficile Associated DiseaseEvaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
NCT03579459
  1. Mobile, Alabama
  2. Tucker, Georgia
  3. New Orleans, Louisiana
  4. Cary, North Carolina
  5. Redding, California
  6. Coral Gables, Florida
  7. DeLand, Florida
  8. Hollywood, Florida
  9. Atlanta, Georgia
  10. Stockbridge, Georgia
  11. Honolulu, Hawaii
  12. Meridian, Idaho
  13. Wichita, Kansas
  14. New Orleans, Louisiana
  15. Norfolk, Nebraska
  16. Omaha, Nebraska
  17. Raritan, New Jersey
  18. Charlotte, North Carolina
  19. Wilmington, North Carolina
  20. Oklahoma City, Oklahoma
  21. Charleston, South Carolina
  22. Austin, Texas
  23. San Antonio, Texas
  24. Draper, Utah
  25. Salt Lake City, Utah
  26. Salt Lake City, Utah
  27. South Jordan, Utah
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Clostridium Difficile Associated DiseaseA Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
NCT02561195
  1. DeLand, Florida
  2. Hollywood, Florida
  3. South Miami, Florida
  4. Honolulu, Hawaii
  5. Overland Park, Kansas
  6. Overland Park, Kansas
  7. Omaha, Nebraska
  8. Las Vegas, Nevada
  9. Raleigh, North Carolina
  10. Wilmington, North Carolina
  11. Cincinnati, Ohio
  12. Cincinnati, Ohio
  13. Austin, Texas
  14. Houston, Texas
  15. San Antonio, Texas
  16. Salt Lake City, Utah
  17. Salt Lake City, Utah
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
Official Title  ICMJE A PHASE 2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TWO 3-DOSE REGIMENS OF A CLOSTRIDIUM DIFFICILE VACCINE IN HEALTHY ADULTS AGED 65 TO 85 YEARS
Brief Summary This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85 years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination schedules. The study will assess the safety and tolerability of the vaccine as well as the subjects' immune response to the vaccine. One year after the third dose subjects that did not receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up to 4 years after their third vaccination.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Clostridium Difficile Associated Disease
Intervention  ICMJE
  • Biological: Clostridium difficile Vaccine
    0.5 mL intramuscular injection.
  • Biological: Placebo
    0.5 mL intramuscular injection
Study Arms  ICMJE
  • Experimental: Low-dose C. difficile Vaccine (accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Experimental: High-dose C. difficile Vaccine (accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Placebo Comparator: Placebo (accelerated schedule)
    Intervention: Biological: Placebo
  • Experimental: Low-dose C. difficile Vaccine (non-accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Experimental: High-Dose C. difficile Vaccine (non-accelerated schedule)
    Intervention: Biological: Clostridium difficile Vaccine
  • Placebo Comparator: Placebo (non-accelerated schedule)
    Intervention: Biological: Placebo
Publications * Kitchin N, Remich SA, Peterson J, Peng Y, Gruber WC, Jansen KU, Pride MW, Anderson AS, Knirsch C, Webber C. A Phase 2 Study Evaluating the Safety, Tolerability, and Immunogenicity of Two 3-Dose Regimens of a Clostridium difficile Vaccine in Healthy US Adults Aged 65 to 85 Years. Clin Infect Dis. 2020 Jan 1;70(1):1-10. doi: 10.1093/cid/ciz153.

*   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: February 11, 2021)		300
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2015)		854
Actual Study Completion Date  ICMJE February 13, 2020
Actual Primary Completion Date March 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female subjects
  • Aged 65 to 85 years

Additional Inclusion Criteria for the extension Stage:

  • Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in the original portion of the study.

Exclusion Criteria:

  • Proven or suspected prior episode of Clostridium difficile associated diarrhea
  • Unstable chronic medical condition
  • Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine
  • Serious chronic disorders
  • Congenital or acquired immunodeficiency disorders
  • Rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications.
  • Active or treated leukemia or lymphoma or bone marrow disorder
  • Any contraindication to vaccination or vaccine components including previous anaphylactic reaction to any vaccine or vaccine-related components

Additional Exclusion Criteria for the Extension Stage:

  • Subjects originally randomized to placebo during the original portion of the study.
  • Subjects who have already completed Visit 9 prior to study unblinding.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02561195
Other Study ID Numbers  ICMJE B5091009
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 February 2021

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