Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study

NCT03918629

Last updated date
Study Location
Hope Research Institute
Phoenix, Arizona, 85018, United States
Contact
1-800-718-1021

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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
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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.

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Advanced Information
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2019)
1960
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2019)
500
Estimated Study Completion Date  ICMJE December 17, 2020
Estimated Primary Completion Date June 9, 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: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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/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 July 2019

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