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 works or clearly doesn't. 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 clinical 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.
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The percentage of participants reporting local reactions
Timeframe: For 7 days after each vaccination
The percentage of participants reporting systemic events
Timeframe: For 7 days after each vaccination
Percentage of participants reporting adverse events
Timeframe: From each vaccination through 1 month after each vaccination
Percentage of participants reporting serious adverse events
Timeframe: From Vaccination 1 (Day 1) through 12 months after Vaccination 2 (last dose) (18 months)
The incidence of the first episode of medically attended and clinically meaningful primary Clostridioides difficile infection (CDI)
Timeframe: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
The incidence of the first episode of medically attended primary CDI
Timeframe: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
The incidence of the first episode of clinically meaningful primary CDI
Timeframe: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
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