A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older

תקציר

The purpose of the study is to learn about how effective, safe, and tolerable the Clostridioides difficile (C. difficile) vaccine is in decreasing the number of C. difficile infections (pCDI) in adults 65 years of age or older. The participants will receive either the C. difficile vaccine or placebo (saline). A placebo does not contain any active ingredients. The vaccines will be given as a shot into the upper arm muscle. This study looks at the number of diarrhea (loose stools) events related to a C. difficile infection, so the length of the study can change. If these events happen quickly, the study may finish sooner; if they happen slowly, it could take longer. Sometimes, the study might stop early if the vaccine clearly does not work. Participants will stay in the study until enough events have occurred to answer the main question. On average, each person is expected to take part for up to about three and a half years. During this time, participants will have 3 planned clinic visits and 3 planned phone visits. After these visits, more scheduled clinic visits will happen every year until the end of study. Besides the scheduled study visits, if at any time during the study a participant has 3 or more loose stools in 24 hours, they will be asked to save the next one (the fourth or later) and contact the study site. The study site will check to see if it could be a C. difficile infection. This check may happen at the clinic or through a phone or video call.

זכאות

תכנון המחקר

מדדי תוצאה

1. מדד תוצאה ראשוני

   The percentage of participants reporting local reactions

   Injection site pain, redness, and swelling as self-reported in electronic diaries

   מסגרת זמן For 7 days after each vaccination

2. מדד תוצאה ראשוני

   The percentage of participants reporting systemic events

   Fever, vomiting, fatigue, headache, muscle pain, and joint pain as self-reported in electronic diaries

   מסגרת זמן For 7 days after each vaccination

3. מדד תוצאה ראשוני

   Percentage of participants reporting adverse events

   As elicited by investigator site staff

   מסגרת זמן From each vaccination through 1 month after each vaccination

4. מדד תוצאה ראשוני

   Percentage of participants reporting serious adverse events

   As elicited by investigator site staff

   מסגרת זמן From Vaccination 1 (Day 1) through 12 months after Vaccination 2 (last dose) (18 months)

5. מדד תוצאה ראשוני

   The incidence of the first episode of medically attended and clinically meaningful primary Clostridioides difficile infection (CDI)

   First episode of medically attended and clinically meaningful primary CDI incidence per 1000 person- years of follow- up

   מסגרת זמן from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)

6. מדד תוצאה ראשוני

   The incidence of the first episode of medically attended primary CDI

   First episode of medically attended primary CDI incidence per 1000 person- years of follow- up

   מסגרת זמן from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)

7. מדד תוצאה ראשוני

   The incidence of the first episode of clinically meaningful primary CDI

   First episode of clinically meaningful primary CDI incidence per 1000 person- years of follow- up

   מסגרת זמן from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)

8. מדד תוצאה משני

   The incidence of antibiotic use in the treatment of a first episode of the primary CDI

   First episode of primary CDI with antibiotic use incidence per 1000 person- years of follow- up

   מסגרת זמן from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)

9. מדד תוצאה משני

   The incidence of severe or fulminant primary CDI

   First episode of severe or fulminant primary CDI incidence per 1000 person- years of follow- up

   מסגרת זמן from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)

10. מדד תוצאה משני

    The incidence of a first episode of primary CDI (any severity)

    First episode of primary CDI incidence per 1000 person- years of follow- up

    מסגרת זמן from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)

11. מדד תוצאה משני

    The incidence of all CDI (primary and recurrent)

    Occurence of all C.difficile infection cases

    מסגרת זמן from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)

תאריכים

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

180 אתרים מגייסים

135 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

1. 9 בספטמבר 2026

   אתר נוסף

   2 sites added (185 total)

   183 → 185

2. 14 באוגוסט 2026

   יעד הגיוס השתנה

   Enrollment target revised up from 32000 to 32500

   32000 → 32500

3. 14 באוגוסט 2026

   אתר נוסף

   9 sites added (183 total)

   174 → 183