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C. difficile vaccine with adjuvant

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment184
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02052726A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.PHASE1 COMPLETED 184 — — Jan 22, 2014May 5, 2015Dec 4, 201810 United States, Canada
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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 — 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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