RANDOMIZED, OBSERVER-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, MULTI-NATIONAL, PHASE III TRIAL IN 15,000 SUBJECTS

Not Applicable

Completed

• Conditions: -A04 Other bacterial intestinal infections; Other bacterial intestinal infections; A04

• Registration Number: PER-015-13
• Lead Sponsor: SANOFI PASTEUR INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-21
• Study Completion: 2018-05-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

1) ≥ 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 required by France and Germany)
5) Must fulfill at least 1 of the following criteria*
Risk Stratum 1:
• Has had at least 2 hospital stays, each lasting at least �� 72 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 ≥ 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.

Exclusion Criteria

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 contraceptiona 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, colostomy, or small or
large intestine bowel surgery where resectio 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 substancesb
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 completiona
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
• Study Design: Not specified