Protection, Immune Response, and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile Infectio

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10054236Term: Clostridium difficile infectionSystem Organ Class: 10021881 - Infections and infestations; Prevention of primary Clostridium difficile infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-000775-32-DE
• Lead Sponsor: Sanofi Pasteur Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-02
• Last Update Posted: 17 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16500

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged = 50 years on the day of inclusion
2) Informed consent form has been signed and dated
3) Able to attend all scheduled visits and to comply with all trial procedures
4) Covered by health insurance (only valid for specific countries)
5) 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
• If an individual is either an in-patient in the hospital or had a previous hospitalization, the enrollment date must be at least 30 days from hospital discharge.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8250

Exclusion Criteria

An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
1) Subject is pregnant, or lactating, or of childbearing potential (to be considered of nonchildbearing 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)
2) 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
3) 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
4) Previous vaccination against C. difficile with either the trial vaccine, another vaccine, or monoclonal antibodies
5) Diarrhea on day of enrollment
6) Self-reported current or prior CDI episode
7) Anticipated or current receipt of kidney dialysis treatment
8) History of gastrointestinal surgery for gastrointestinal malignancy (Note: Colonoscopy, polypectomy, and appendectomy are not exclusion criteria.)
9) History of inflammatory bowel disease, irritable bowel syndrome (must include diarrhea as a symptom), colostomy, or small or large intestine bowel surgery where resection was performed
10) Receiving enteral feeding (e.g., nasogastric, gastrostomy, and jejunostomy tube feeding)
11) 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)
12) Known systemic hypersensitivity to any of the vaccine components, or history of a lifethreatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
13) Self-reported thrombocytopenia, contraindicating IM vaccination
14) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
15) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures in the opinion of the Investigator
16) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
17) 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
18) 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified