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C. difficile vaccine

Phase 1

Clostridium Difficile Associated Disease | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Mar 6, 2014

Target and mechanism

ModalityMonoclonal antibody

Also known as C. difficile vaccine (previously studied formulation)., C.difficile vaccine

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment192

FDA Designations

No designations recorded

Clinical trial landscape

C. difficile vaccine · 1 trial · 1 indication

Phase 1 1
NCT01706367Evaluation of a 3-dose Vaccination Regimen With One of Three Ascending Dose Levels of Clostridium Difficile Vaccine With or Without Adjuvant in Healthy Adults Aged 50 to 85 YearsClostridium Difficile Associated Disease
COMPLETED192 Analytics
PHASE1COMPLETED
Evaluation of a 3-dose Vaccination Regimen With One of Three Ascending Dose Levels of Clostridium Difficile Vaccine With or Without Adjuvant in Healthy Adults Aged 50 to 85 Years
Clostridium Difficile Associated Disease
NCT01706367192
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Study Endpoints

Primary Endpoints

Number subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on eDiaries for 7 days following each vaccination.
7 days
Number of subjects reporting systemic reactions (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on eDiaries for 7 days following each vaccination.
7 days
Number of subjects reporting AEs from day 1 (at the time of vaccination) up to 28 days post Dose 3 (visit 9, month 7) and SAEs throughout the study period.
7 months (AEs) 12 months (SAEs)
Number of subjects with abnormal hematology and blood chemistry laboratory assessments after each vaccination dose.
Day 3, Day 14, Month 1, Day 37, Month 6, Day 187

Secondary Endpoints

Neutralizing antibody levels at Month 2.
Month 2
Neutralizing antibody levels after each vaccination dose.
Baseline, Day 14, Month 1, Day 37, Month 6, Day 187, Month 7
Number of subjects in each treatment group with 4 and higher fold-rises in neutralizing antibody levels after each vaccination dose.
Baseline, Day 14, Month 1, Day 37, Month 2, Month 6, Day 187, Month 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Low dose C diff vaccineEXPERIMENTAL -
Low dose C diff vaccine + adjuvantEXPERIMENTAL -
Mid dose C diff vaccineEXPERIMENTAL -
Mid dose C diff vaccine + adjuvantEXPERIMENTAL -
High dose C diff vaccineEXPERIMENTAL -
High dose C diff vaccine + adjuvantEXPERIMENTAL -

Interventions

NameTypeDescription
C. difficile vaccineBIOLOGICAL0.5 mL IM injection
C. difficile vaccine +adjuvantBIOLOGICAL0.5 mL IM injection
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Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document. 2. Healthy male and female adults aged 50 to 85 years at enrollment as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subject...

Countries:United States
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Frequently asked questions about C. difficile vaccine

What is C. difficile vaccine used for?

C. difficile vaccine is an investigational vaccine being developed to prevent Clostridium difficile associated disease, also referred to as Clostridioides difficile associated disease. It is intended for use in adults, with clinical studies evaluating regimens in healthy adults aged 50 to 85 years and in people 65 years of age and older.

Who makes C. difficile vaccine?

C. difficile vaccine is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The vaccine is currently in clinical development and has not been approved by regulatory authorities.

What phase is C. difficile vaccine in?

C. difficile vaccine is in Phase 1 clinical development. Early-stage trials have been completed, and a Phase 3 study is currently recruiting participants. The vaccine remains investigational and is not yet approved for commercial use.

What clinical trials is C. difficile vaccine in?

C. difficile vaccine has been studied in several clinical trials. Completed Phase 1 trials include NCT01706367 and NCT02052726, which evaluated 3-dose regimens in healthy adults aged 50 to 85 years. A Phase 3 trial, NCT07282665, is currently recruiting 32,500 participants aged 65 years and older.

Is C. difficile vaccine the same as C.difficile vaccine?

Yes, C. difficile vaccine is also known as C.difficile vaccine. The alternative name refers to the same investigational vaccine developed by Pfizer, Inc. for the prevention of Clostridium difficile associated disease.