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C.difficile vaccine

Phase 3

Clostridioides Difficile Associated Disease | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: May 26, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment32,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07282665A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and OlderPHASE3 RECRUITING 32,000 — — Dec 10, 2025Jun 7, 2029May 26, 2026174 United States, Argentina +2
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Study Endpoints
Primary Endpoints
The percentage of participants reporting local reactions
For 7 days after each vaccination

Injection site pain, redness, and swelling as self-reported in electronic diaries

The percentage of participants reporting systemic events
For 7 days after each vaccination

Fever, vomiting, fatigue, headache, muscle pain, and joint pain as self-reported in electronic diaries

Percentage of participants reporting adverse events
From each vaccination through 1 month after each vaccination

As elicited by investigator site staff

Percentage of participants reporting serious adverse events
From Vaccination 1 (Day 1) through 12 months after Vaccination 2 (last dose) (18 months)

As elicited by investigator site staff

The incidence of the first episode of medically attended and clinically meaningful primary Clostridioides difficile infection (CDI)
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)

First episode of medically attended and clinically meaningful primary CDI incidence per 1000 person- years of follow- up

The incidence of the first episode of medically attended primary CDI
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)

First episode of medically attended primary CDI incidence per 1000 person- years of follow- up

The incidence of the first episode of clinically meaningful primary CDI
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)

First episode of clinically meaningful primary CDI incidence per 1000 person- years of follow- up

Secondary Endpoints
The incidence of antibiotic use in the treatment of a first episode of the primary CDI
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
The incidence of severe primary CDI as defined by Infectious Diseases Society of America (IDSA)/ Society for Healthcare Epidemiology of America (SHEA)
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
The incidence of a first episode of primary CDI (any severity)
from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
C.difficile vaccineEXPERIMENTALNovel vaccine formulation
Saline PlaceboOTHER -
Interventions
NameTypeDescription
C.difficile vaccineBIOLOGICALC.difficile vaccine given as an intramuscular injection
Saline PlaceboOTHER0.9% sodium chloride solution given as a intramuscular injection
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Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites174

Who Can Join the Study (Inclusion Criteria): • People with recent or future planned contact with healthcare systems or who have recently received antibiotics. Who Cannot Join the Study (Exclusion Criteria): * Anyone who has had CDI before. * Anyone who has had surgery to remove part of their smal...

Countries:United StatesArgentinaJapanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 27, 2026NCT07282665lastUpdatePostDate: changed
LOWMay 27, 2026NCT07282665lastUpdatePostDate: changed
LOWMay 26, 2026NCT07282665primaryCompletionDate: changed
LOWMay 24, 2026NCT07282665studyFirstPostDate: changed