Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

  • STATUS
    Recruiting
  • sponsor
    Sanofi Pasteur
Updated on 25 March 2021

Summary

Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Description

The aim of this study is to evaluate the efficacy of the candidate Clostridium difficile (C. difficile) vaccine to prevent primary symptomatic C. difficile infection (CDI) in subjects a risk for CDI where there is a substantial unmet medical need.

Details
Clinical Study IdentifierTX138622
SponsorSanofi Pasteur
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged ≥ 50 years on the day of inclusion
Informed consent form has been signed and dated
Able to attend all scheduled visits and to comply with all trial procedures
Covered by health insurance (if required)
Must fulfill at least 1 of the following criteria
Risk Stratum 1
Has had at least 2 hospital stays, each lasting at least = 24 hours, in the 12 months before enrollment, and
Has received systemic (not topical) antibiotics in the 12 months before enrollment, or
Risk Stratum 2
Is anticipated to have an in-patient hospitalization for a planned surgical procedure within 60 days of enrollment. The impending hospital stay is planned to be = 72 hours for a surgery involving 1 of the following
Kidney/bladder/urinary system
Musculoskeletal system
Respiratory system
Circulatory system
Central nervous system

Exclusion Criteria

Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
Participation in the 4 weeks preceding the first trial vaccination or participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for influenza (seasonal or pandemic) and pneumococcal vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
Previous vaccination against C. difficile with either the trial vaccine, another vaccine, or monoclonal antibodies
Diarrhea on day of enrollment
Self-reported current or prior CDI episode
Anticipated or current receipt of kidney dialysis treatment
History of gastrointestinal surgery for gastrointestinal malignancy (Note: Colonoscopy, polypectomy, and appendectomy are not exclusion criteria.)
History of inflammatory bowel disease, irritable bowel syndrome, colostomy, or small or large intestine bowel surgery where resection was performed
Receiving enteral feeding (e.g., nasogastric, gastrostomy, and jejunostomy tube feeding)
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
Self-reported thrombocytopenia, contraindicating intramuscular vaccination
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures in the opinion of the Investigator
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C [= 100.4°F]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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