Alliance for Multispecialty Research, LLC | AMR Coral Gables, FL
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About
An antibody is a substance your body makes to fight off infection. This study will explore the safety and antibody response of a vaccine to prevent severe diarrhea caused by a germ called Clostridoides difficile (C. diff). Three new formulations of the C. diff vaccine will be used in this study, in addition to a C. diff vaccine formulation that has been studied in previous clinical trials.
The purpose of this study is to understand if giving the new C. diff vaccine formulations helps people make as many antibodies as giving the previously studied C. diff vaccine formulation.
The study is divided into 2 phases.
Phase 1 will evaluate 3 new formulations of the C. diff vaccine and 2 dosing schedules spread out over 2 months or 6 months.
The Phase 1 portion of the study is seeking participants:
All participants in Phase 1 will receive study injections with active vaccine or placebo at each vaccination visit, depending on the vaccine group to which they are assigned. A placebo does not contain any active ingredients. Participants in Phase 1 will attend at least 9 study visits and will take part in the study for approximately 18 months. Based on the results of Phase 1, 1 or 2 of the new C. diff vaccine formulations will be chosen for further study in Phase 2.
Phase 2 will evaluate the safety and effects of the new C. diff vaccine formulation(s) chosen in Phase 1.
The Phase 2 portion of the study is seeking participants:
All Phase 2 participants will receive active C. diff vaccine or placebo at each vaccination visit. Participants in Phase 2 will attend at least 6 and up to 12 study visits and will take part in the study for approximately 4 years.
Enrollment
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Volunteers
Inclusion criteria
Each phase of the study will enroll participants in different age categories:
Phase 1: Participants ≥65 to <85 years of age; Phase 2: Participants ≥65 years of age.
Healthy participants as determined by medical history, clinical assessment, and the judgment of the investigator.
Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
Capable of giving personally signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
755 participants in 13 patient groups
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Central trial contact
Pfizer CT.gov Call Center
Data sourced from clinicaltrials.gov
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