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 range65 Years – 85 Years
SexALL
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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…
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
7
Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3