Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age (NCT03579459) | Clinical Trial Compass
CompletedPhase 3
Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
United States1,317 participantsStarted 2018-07-31
Plain-language summary
This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years of age, who will each receive 3 doses of vaccine. The study will assess the lot consistency, safety, and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.
Who can participate
Age range
65 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Evidence of a personally signed and dated informed consent document.
* Willing and able to comply with study procedures.
* Healthy adults 65 to 85 years of age.
* Male subjects or female subjects who are not of childbearing potential.
* Ability to be contacted by telephone during study participation.
Exclusion Criteria:
* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
* Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry through conclusion of the study.
* Previous administration of an investigational C difficile vaccine or C difficile monoclonal antibody therapy.
* Proven or suspected prior episode of C difficile infection.
* Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of investigational product.
* Serious chronic medical disorders, including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease.
* Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
* Any contraindicatio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
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.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric Mean Concentrations (GMCs) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7
Timeframe: At Month 7
2
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1
Timeframe: Within 7 days after Vaccination 1 at Month 0
3
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2
Timeframe: Within 7 days after Vaccination 2 at Month 1
4
Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3
Timeframe: Within 7 days after Vaccination 3 at Month 6
5
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1
Timeframe: Within 7 days after Vaccination 1 at Month 0
6
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2
Timeframe: Within 7 days after Vaccination 2 at Month 1