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Trial record 1 of 1 for:    NCT03918629
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Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study

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ClinicalTrials.gov Identifier: NCT03918629
Recruitment Status : Completed
First Posted : April 17, 2019
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 2, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date March 24, 2021
Actual Study Start Date  ICMJE April 1, 2019
Actual Primary Completion Date December 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • C difficile toxin A- and toxin B-specific neutralizing antibody levels at Month 7 in each regimen [ Time Frame: At Month 7 ]
    As measured by the central laboratory
  • Percentage of subjects reporting local reactions [ Time Frame: Up to 7 days following each vaccination ]
    Pain, erythema, and induration, as self-reported in electronic diaries
  • Percentage of subjects reporting systemic events [ Time Frame: Up to 7 days following each vaccination ]
    Fever, vomiting, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain, as self-reported in electronic diaries
  • Percentage of subjects reporting nonserious adverse events [ Time Frame: Up to 1 month after the last dose of vaccine ]
    As elicited by investigational site staff
  • Percentage of subjects reporting serious adverse evets [ Time Frame: Up to 6 months after the last dose of vaccine ]
    As elicited by investigational site staff
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
Toxin A- and toxin B-specific neutralizing antibody levels, expressed as geometric mean concentrations in each regimen [ Time Frame: At Month 12 ]
As measured by the central laboratory
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study
Official Title  ICMJE A PHASE 3, RANDOMIZED OBSERVER-BLINDED STUDY TO EVALUATE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF 2 DOSES COMPARED TO 3 DOSES OF CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER
Brief Summary This study will investigate a Clostridium difficile vaccine in healthy adults 50 years of age and older. In half the healthy adults, all 3 doses given are the Clostridium difficile vaccine, and in half the healthy adults, 2 of the 3 doses are the Clostridium difficile vaccine with the other dose containing no active ingredients. The study will look at the subjects' immune response to the vaccine and assess the safety and tolerability of a 2-dose regimen of Clostridium difficile vaccine compared to a 3-dose regimen of Clostridium difficile vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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
    Toxoid-based Clostridium difficile vaccine
  • Biological: Placebo
    Normal saline solution (0.9% sodium chloride)
Study Arms  ICMJE
  • Experimental: Clostridium difficile vaccine - 3 dose
    All 3 doses are the Clostridium difficile vaccine
    Intervention: Biological: Clostridium difficile
  • Experimental: Clostridium difficile vaccine - 2 dose
    2 of the 3 doses are the Clostridium difficile vaccine with the other being placebo
    Interventions:
    • Biological: Clostridium difficile
    • Biological: Placebo
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: March 22, 2021)
2004
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2019)
500
Actual Study Completion Date  ICMJE December 22, 2020
Actual Primary Completion Date December 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document.
  • Willing and able to comply with study procedures.
  • Subjects with an increased risk of future contact with healthcare systems or subjects who have received systemic antibiotics in the previous 12 weeks.
  • Ability to be contacted by telephone during study participation.

Exclusion Criteria:

  • Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP); and WOCBP who are, in the opinion of the investigator, sexually active and at risk for pregnancy and are unwilling or unable to use effective methods of contraception as outlined in this protocol from the signing of the informed consent until at least 28 days after the last dose of investigational product.
  • Prior episode of CDI, confirmed by either laboratory test or diagnosis of pseudomembranous colitis at colonoscopy, at surgery, or histopathologically.
  • Participants who may be unable to respond to vaccination due to:

    • Metastatic malignancy; or
    • End-stage renal disease (glomerular filtration rate <15 mL/min/1.73 m2 or on dialysis).
    • Any serious medical disorder that in the investigator's opinion is likely to be fatal within the next 12 months.
    • Congenital or acquired immunodeficiency.
  • Known infection with human immunodeficiency virus (HIV).
  • Any bleeding disorder or anticoagulant therapy that would contraindicate IM injection.
  • Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior 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.
  • Previous administration of an investigational C difficile vaccine or C difficile mAb therapy.
  • Receipt of systemic corticosteroids for greater than or equal to 14 days within 28 days before enrollment.
  • Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months before enrollment.
  • Receipt of blood products or immunoglobulins within 6 months before enrollment.
  • Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until 1 month after the third vaccination.
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, 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 NCT03918629
Other Study ID Numbers  ICMJE B5091019
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2021

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