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Cancer Vaccine
C. difficile Vaccine for C. difficile Infection
Phase 1 & 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from before vaccination 5 (month 13 or 14), each planned persistence time point (month 26, 38 and 50)
Awards & highlights
Study Summary
This trial is studying the safety & antibody response of a vaccine to prevent severe diarrhea from a germ called C. diff. Healthy adults of ages 50-84 are needed for the study. They will receive active vaccine/placebo, and be followed for 4.5 years.
Who is the study for?
Healthy adults aged 65-84 for Phase 1, and 50-84 for Phase 2, who've never had a C. diff infection or received any C. diff vaccine or therapy. Participants must be able to follow the study plan and give informed consent. Exclusions include those on immunosuppressive therapy, involved in other investigational studies, with certain medical conditions or history of severe allergies to vaccines.Check my eligibility
What is being tested?
The trial is testing three new formulations of a C. difficile vaccine against one previously studied formulation and a saline placebo to see if they're safe and can help the body produce antibodies against C. diff infection. The study has two phases: Phase 1 tests different dosing schedules; based on these results, one or two formulations will advance to Phase 2.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects from vaccines may include pain at injection site, fatigue, headache, muscle pain, chills, fever and nausea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from before vaccination 5 (month 13 or 14), each planned persistence time point (month 26, 38 and 50)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from before vaccination 5 (month 13 or 14), each planned persistence time point (month 26, 38 and 50)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Percentage of participants reporting adverse events
Phase 1: Percentage of participants reporting local reactions
Phase 1: Percentage of participants reporting systemic events
+2 moreSecondary outcome measures
Phase 1: Geometric mean concentration (GMC) of C. difficile toxin A- and toxin B-specific neutralizing antibodies
Phase 1: Geometric mean fold-rise (GMFR) of C. difficile toxin A- and toxin B-specific neutralizing antibody concentrations
Phase 1: Percentage of participants reporting medically attended adverse events
+13 moreTrial Design
12Treatment groups
Experimental Treatment
Active Control
Group I: C. difficile vaccine formulation 3, 6-month schedule (Phase 1)Experimental Treatment2 Interventions
Novel vaccine formulation 3
Group II: C. difficile vaccine formulation 3, 2-month schedule (Phase 1)Experimental Treatment2 Interventions
Novel vaccine formulation 3
Group III: C. difficile vaccine formulation 2. Schedule 2 with booster (Phase 2)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group IV: C. difficile vaccine formulation 2. Schedule 2 (Phase 2)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group V: C. difficile vaccine formulation 2. Schedule 1 (Phase 2)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group VI: C. difficile vaccine formulation 2, 6-month schedule (Phase 1)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group VII: C. difficile vaccine formulation 2, 2-month schedule (Phase 1)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group VIII: C. difficile vaccine formulation 1, 6-month schedule (Phase 1)Experimental Treatment2 Interventions
Novel vaccine formulation 1
Group IX: C. difficile vaccine formulation 1, 2-month schedule(Phase 1)Experimental Treatment2 Interventions
Novel vaccine formulation 1
Group X: C difficile vaccine formulation 2. Schedule 1 with booster (Phase 2)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group XI: C. difficile vaccine (previously studied formulation) 6-months schedule (Phase 1)Active Control2 Interventions
Previously studied C. difficile vaccine formulation
Group XII: C. difficile vaccine (previously studied formulation) , 6-month schedule (Phase 2)Active Control2 Interventions
Previously studied C. difficile vaccine formulation
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
PfizerLead Sponsor
4,568 Previous Clinical Trials
10,911,336 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,092,504 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never received an experimental vaccine or antibody therapy for C. difficile.I can sign the consent form and follow the study's rules.I do not have a serious chronic disorder that would prevent me from joining the study.I am willing and able to follow all study requirements.I am not on immunosuppressive therapy or have taken corticosteroids in the last 28 days.My blood tests show at least one mild abnormality.I am not pregnant or breastfeeding and willing to use birth control during the study.I have had a confirmed case of C. diff infection before.I have a condition that weakens my immune system.I have not received blood products or immunoglobulin in the last 6 months.You are considered medically healthy based on your history, examination, and the investigator's discretion.I do not have a bleeding disorder or take blood thinners that prevent muscle injections.I am between 65 and 85 years old for Phase 1, or between 50 and 85 for Phase 2.You cannot receive the vaccine because you've had a severe allergic reaction to any vaccine or its components before.You have any medical or mental health condition that could put you at risk while participating in the study. This includes recent suicidal thoughts or behavior. The doctor in charge of the study will determine if it is safe for you to participate.
Research Study Groups:
This trial has the following groups:- Group 1: C. difficile vaccine formulation 1, 2-month schedule(Phase 1)
- Group 2: C. difficile vaccine formulation 2. Schedule 2 with booster (Phase 2)
- Group 3: C. difficile vaccine (previously studied formulation) 6-months schedule (Phase 1)
- Group 4: C. difficile vaccine formulation 2. Schedule 1 (Phase 2)
- Group 5: C. difficile vaccine (previously studied formulation) , 6-month schedule (Phase 2)
- Group 6: C. difficile vaccine formulation 2. Schedule 2 (Phase 2)
- Group 7: C difficile vaccine formulation 2. Schedule 1 with booster (Phase 2)
- Group 8: C. difficile vaccine formulation 1, 6-month schedule (Phase 1)
- Group 9: C. difficile vaccine formulation 3, 6-month schedule (Phase 1)
- Group 10: C. difficile vaccine formulation 3, 2-month schedule (Phase 1)
- Group 11: C. difficile vaccine formulation 2, 2-month schedule (Phase 1)
- Group 12: C. difficile vaccine formulation 2, 6-month schedule (Phase 1)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants aged 45 or younger eligible for this trial?
"The lower limit of age eligibility for this medical study is 50 years, while the upper threshold stands at 84."
Answered by AI
How many participants is this trial accommodating?
"Correct. The clinicaltrials.gov website confirms that this research study, posted on March 23rd 2023, is currently seeking participants. 355 patients need to be enrolled from 9 distinct medical centres."
Answered by AI
Is this experiment currently enrolling participants?
"Indeed, the clinical trial is still open for enrollment. The information was first posted on March 23rd 2023 and has since been modified as of April 6th 2023 - per data collected from clinicaltrials.gov."
Answered by AI
Is eligibility to enroll in this research project open to me?
"To be eligible for this study, individuals must have c. difficile infection and be between the ages of 50-84 years old. Up to 355 people can enroll in this medical trial."
Answered by AI
Are there a number of sites in North America that are actively conducting this research?
"Participants are welcome to join at Indago Research & Health Center, Inc in Hialeah, Florida as well as Research Centers of America (Hollywood) in Hollywood and New Horizon Research Centre located in Miami. Additionally, there are 9 more clinical trial sites."
Answered by AI
What ultimate results is this medical study attempting to achieve?
"Pfizer, the clinical trial sponsor, has identified that the primary outcome over a 7 day period is the percentage of participants reporting systemic events. Furthermore they will be analysing secondary outcomes including GMFR and GMC of C. difficile toxin A- and toxin B-specific neutralizing antibody concentrations as measured at central laboratory."
Answered by AI
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