This study will investigate a Clostridium difficile vaccine in adults 50 years of age and older. In half the adults, all 3 doses given are the Clostridium difficile vaccine, and in half the adults, 2 of the 3 doses are the Clostridium difficile vaccine with the other dose containing no active ingredients. The study will look at the subjects' immune response to the vaccine and assess the safety and tolerability of a 2-dose regimen of Clostridium difficile vaccine compared to a 3-dose regimen of Clostridium difficile vaccine.
Age range
50 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Adjusted Geometric Mean Concentration (GMC) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7 for Evaluable Immunogenicity Population (EIP)
Timeframe: Month 7
Percentage of Participants Achieving Seroresponse for Clostridium Difficile Toxin A and Toxin B at Month 7 for EIP
Timeframe: Month 7
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Timeframe: Up to 7 days after Dose 1 of investigational product at Month 0
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Timeframe: Up to 7 days after Dose 2 of investigational product at Month 1
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Timeframe: Up to 7 days after Dose 3 of investigational product at Month 6
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Timeframe: Up to 7 days after Dose 1 of investigational product at Month 0
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Timeframe: Up to 7 days after Dose 2 of investigational product at Month 1
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Timeframe: Up to 7 days after Dose 3 of investigational product at Month 6
Percentage of Participants With Adverse Events Through 1 Month After Last Study Vaccination
Timeframe: From day of first dose up to 1 month after last dose (up to Month 7)
Percentage of Participants With Serious Adverse Events (SAEs) Through 6 Months After Last Study Vaccination
Timeframe: From day of first dose up to 6 months after last dose (up to Month 12)