Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03090191
Previous Study | Return to List | Next Study

Clostridium Difficile Vaccine Efficacy Trial (Clover)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03090191
Recruitment Status : Active, not recruiting
First Posted : March 24, 2017
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 20, 2017
First Posted Date  ICMJE March 24, 2017
Last Update Posted Date June 17, 2019
Actual Study Start Date  ICMJE March 29, 2017
Estimated Primary Completion Date September 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • First primary case CDI incidence [ Time Frame: Up to 3 years after the 3rd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)
  • First primary case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)
  • Percentage of subjects reporting local reactions [ Time Frame: Up to 7 days following each vaccination, 1, 2, and 3 ]
    Pain, erythema, and induration, as self-reported on electronic diaries
  • Percentage of subjects reporting systemic events [ Time Frame: Up to 7 days following each vaccination, 1, 2, and 3 ]
    Fever, vomiting, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain, as self-reported on electronic diaries
  • Percentage of subjects reporting nonserious adverse events [ Time Frame: Up to 7 months after the first dose ]
    As elicited by investigational site staff
  • Percentage of subjects reporting serious adverse events [ Time Frame: Up to 12 months after the first dose ]
    As elicited by investigational site staff
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
  • First primary case CDI incidence per 1000 person-years of follow-up (confirmed at the central laboratory) [ Time Frame: Up to 3 years after the 3rd dose. ]
  • First primary case CDI incidence per 1000 person-years of follow-up (confirmed at the central laboratory) [ Time Frame: Up to 3.4 years after the 2nd dose. ]
  • Percentage of subjects reporting local reactions (pain, erythema, and induration), as self-reported on electronic diaries. [ Time Frame: Up to 7 days following each vaccination, 1, 2, and 3 ]
  • Percentage of subjects reporting systemic events (fever, vomiting, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain), as self-reported on electronic diaries. [ Time Frame: Up to 7 days following each vaccination, 1, 2, and 3 ]
  • Percentage of subjects reporting nonserious adverse events. [ Time Frame: Up to 7 months after the first dose. ]
  • Percentage of subjects reporting serious adverse events. [ Time Frame: Up to 12 months after the first dose. ]
Change History Complete list of historical versions of study NCT03090191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • All case CDI incidence [ Time Frame: Up to 3 years after the 3rd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)
  • Mean time to resolution of diarrhea in first primary cases of CDI [ Time Frame: Up to 3.5 years after enrolment ]
    Confirmed at the central laboratory
  • Proportion of subjects experiencing a first primary episode of CDI who have a non-protocol-related medically attended visit during the CDI episode [ Time Frame: Up to 3.5 years after enrolment ]
    Confirmed at the central laboratory
  • Recurrent case CDI incidence [ Time Frame: Up to 3 years after the 3rd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)
  • All case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)
  • Recurrent case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)
  • In subjects that receive only 2 doses, first primary CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)
  • In subjects that receive only 2 doses, recurrent case CDI incidence [ Time Frame: Up to 3.4 years after the 2nd dose ]
    Per 1000 person-years of follow-up (confirmed at the central laboratory)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
  • Recurrent case CDI incidence per 1000 person-years of follow-up (confirmed at the central laboratory). [ Time Frame: Up to 3 years after the 3rd dose. ]
  • Recurrent case CDI incidence per 1000 person-years of follow-up (confirmed at the central laboratory). [ Time Frame: Up to 3.4 years after the 2nd dose. ]
  • First primary case CDI incidence per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile). [ Time Frame: Up to 3 years after the 3rd dose. ]
  • First primary case CDI incidence per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile). [ Time Frame: Up to 3.4 years after the 2nd dose. ]
  • Recurrent case CDI incidence per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile). [ Time Frame: Up to 3 years after the 3rd dose. ]
  • Recurrent case CDI incidence per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile). [ Time Frame: Up to 3.4 years after the 2nd dose. ]
  • In subjects that receive only 2 doses, first primary CDI incidence per 1000 person-years of follow-up (confirmed at the central laboratory). [ Time Frame: Up to 3.4 years after the 2nd dose. ]
  • In subjects that receive only 2 doses, recurrent case CDI incidence per 1000 person-years of follow-up (confirmed at the central laboratory). [ Time Frame: Up to 3.4 years after the 2nd dose. ]
  • In subjects that receive only 2 doses, first primary case CDI incidence per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile). [ Time Frame: Up to 3.4 years after the 2nd dose. ]
  • In subjects that receive only 2 doses, recurrent case CDI incidence per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile). [ Time Frame: Up to 3.4 years after the 2nd dose. ]
  • All case CDI incidence per 1000 person-years of follow-up (confirmed at the central laboratory). [ Time Frame: Up to 3 years after the 3rd dose. ]
  • All case CDI incidence per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile). [ Time Frame: Up to 3 years after the 3rd dose. ]
  • All case CDI incidence per 1000 person-years of follow-up (confirmed at the central laboratory). [ Time Frame: Up to 3.4 years after the 2nd dose. ]
  • All case CDI incidence per 1000 person-years of follow-up (including local laboratory demonstration of the presence of Clostridium difficile). [ Time Frame: Up to 3.4 years after the 2nd dose. ]
  • Mean time to resolution of diarrhea in first primary cases of CDI (confirmed at the central laboratory). [ Time Frame: Up to 3.5 years after enrolment. ]
  • Proportion of subjects experiencing a first primary episode of CDI (confirmed at the central laboratory) who have a non-protocol-related medically attended visit during the CDI episode. [ Time Frame: Up to 3.5 years after enrolment. ]
  • Mean ATLAS (age, treatment with systemic antibiotics during CDI therapy, leukocyte count, serum albumin, and serum creatinine) score. [ Time Frame: Up to 3.5 years after enrolment. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Description Not 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: June 13, 2019)
17454
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2017)
15776
Estimated Study Completion Date  ICMJE September 28, 2020
Estimated Primary Completion Date September 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 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 June 2019

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