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Clostridium Difficile Vaccine Efficacy Trial

Last updated on November 13, 2019

Study Website
Study Location
North Alabama Research Center, LLC
Athens, Alabama, 35611 United States
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Clostridium Difficile Infection
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.

- Negative urine pregnancy test for female subjects of childbearing potential.

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

- 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
subjects who are Pfizer employees, including their family members, directly involved
in the conduct of the study.

- Participation in other studies involving investigational drug(s)/vaccine(s) within 28
days prior to study entry until 1 month after the third vaccination.

- Previous administration of an investigational C difficile vaccine or C difficile mAb
therapy.

- Prior episode of CDI..

- Receipt of blood products or immunoglobulins within 6 months before enrollment.

- Subjects who may be unable to respond to vaccination due to:

- Metastatic malignancy; or

- End-stage renal disease; or

- Any serious medical disorder likely to be fatal within the next 12 months; or

- Congenital or acquired immunodeficiency; or

- Receipt of high dose systemic corticosteroids for 14 days within 28 days of
enrollment; or

- Receipt of chronic systemic treatment with other known immunosuppressant
medications, or radiotherapy, within 6 months of enrollment.

- Known infection with human immunodeficiency virus (HIV).

- Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular
injection.

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

- Prior small- or large-bowel resection.

- Any condition or treatment resulting in frequent diarrhea.

- Other acute or chronic condition or abnormality that may increase the risk associated
with study participation or IP administration or may interfere with interpretation of
study results

- Pregnant or breastfeeding female subjects; male subjects and female subjects who are
sexually active and at risk for pregnancy and will not/cannot use 2 methods of
contraception

NCT03090191
Pfizer
Active, not recruiting
Clostridium Difficile Vaccine Efficacy Trial

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For Patients: Please visit the study website for more information

All other inquiries: Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE Clostridium Difficile Vaccine Efficacy Trial
Official Title  ICMJE A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER
Brief Summary

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.

Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Clostridium Difficile Infection
Intervention  ICMJE
  • Biological: Clostridium difficile vaccine
    Toxoid-based Clostridium difficile vaccine
  • Biological: Placebo
    Normal saline solution (0.9% sodium chloride)
Study Arms  ICMJE
  • Experimental: Clostridium difficile vaccine
    Intervention: Biological: Clostridium difficile vaccine
  • Placebo Comparator: Placebo
    Intervention: 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 25, 2019)
17525
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2017)
15776
Estimated Study Completion Date  ICMJE September 28, 2020
Estimated Primary Completion DateSeptember 28, 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.
  • Negative urine pregnancy test for female subjects of childbearing potential.

Exclusion Criteria:

  • 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 subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until 1 month after the third vaccination.
  • Previous administration of an investigational C difficile vaccine or C difficile mAb therapy.
  • Prior episode of CDI..
  • Receipt of blood products or immunoglobulins within 6 months before enrollment.
  • Subjects who may be unable to respond to vaccination due to:

    • Metastatic malignancy; or
    • End-stage renal disease; or
    • Any serious medical disorder likely to be fatal within the next 12 months; or
    • Congenital or acquired immunodeficiency; or
    • Receipt of high dose systemic corticosteroids for 14 days within 28 days of enrollment; or
    • Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
  • Known infection with human immunodeficiency virus (HIV).
  • Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
  • Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
  • Prior small- or large-bowel resection.
  • Any condition or treatment resulting in frequent diarrhea.
  • Other acute or chronic condition or abnormality that may increase the risk associated with study participation or IP administration or may interfere with interpretation of study results
  • Pregnant or breastfeeding female subjects; male subjects and female subjects who are sexually active and at risk for pregnancy and will not/cannot use 2 methods of contraception
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 Argentina,   Australia,   Belgium,   Bulgaria,   Canada,   Chile,   Colombia,   Czechia,   Finland,   France,   Germany,   Hungary,   Japan,   Korea, Republic of,   Peru,   Poland,   Portugal,   Slovakia,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03090191
Other Study ID Numbers  ICMJE B5091007
2016-003866-14 ( EudraCT Number )
CLOVER ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
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/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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]

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