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Clostridium Difficile Vaccine Efficacy Trial

Last updated on July 20, 2018

FOR MORE INFORMATION
Study Location
North Alabama Research Center, LLC
Athens, Alabama, 35611 United States
Contact
1-800-718-1021
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
Recruiting
Clostridium Difficile Vaccine Efficacy Trial

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Pfizer Clinical Trials Contact Center

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[email protected]

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Clostridium Difficile Vaccine Efficacy Trial
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Clostridium Difficile Infection
  • Biological: Clostridium difficile vaccine
    Toxoid-based Clostridium difficile vaccine
  • Biological: Placebo
    Normal saline solution (0.9% sodium chloride)
  • Experimental: Clostridium difficile vaccine
    Intervention: Biological: Clostridium difficile vaccine
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15776
September 28, 2020
September 28, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
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
 
 
NCT03090191
B5091007
2016-003866-14 ( EudraCT Number )
CLOVER ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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