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C. difficile vaccine with adjuvant

Phase 1

Clostridium Difficile | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Dec 4, 2018

Target and mechanism

ModalityMonoclonal antibody

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment184

FDA Designations

No designations recorded

Clinical trial landscape

C. difficile vaccine with adjuvant · 1 trial · 1 indication

Phase 1 1
NCT02052726A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.Clostridium Difficile
COMPLETED184 Analytics
PHASE1COMPLETED
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
Clostridium Difficile
NCT02052726184
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Study Endpoints

Primary Endpoints

Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.
7 days after vaccination
Proportion of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on e-diaries.
7 days after vaccination

Secondary Endpoints

Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s).
Up to 12 months post-dose 3
Proportion of subjects in each vaccine group with neutralizing antibody levels, expressed as geometric mean concentrations (GMCs) (in Neut units/mL).
Up to 12 months post-dose 3
Proportion of subjects in each vaccine group with a greater than or equal to 4 and higher fold-rises in neutralizing antibody levels (in Neut units/mL).
Up to 12 months post-dose 3
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm Label: Month 0, 1 and 3 ScheduleEXPERIMENTAL -
Day 1, 8, and 30 ScheduleEXPERIMENTAL -

Interventions

NameTypeDescription
C. difficile vaccine with adjuvantBIOLOGICALC. difficile vaccine with adjuvant administered at Month 0, 1, and 3.
PlaceboBIOLOGICALPlacebo administered at Month 0, 1, and 3.
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Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: * Healthy male and female adults aged 50 to 85 years at enrollment Exclusion Criteria: * Proven or suspected prior episode of Clostridium difficile associated diarrhea. * Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization f...

Countries:United StatesCanada
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Frequently asked questions about C. difficile vaccine with adjuvant

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.