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C. difficile toxoid vaccine

Phase 1

Clostridium Infections | Monoclonal antibody | Other |Sanofi|Last Updated: Apr 11, 2012

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00214461Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly VolunteersPHASE1 COMPLETED 48 — — Nov 1, 2005Feb 1, 2006Apr 11, 20122 United States
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Study Endpoints
Primary Endpoints
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Day 0 to up to 70 days post first vaccination
Secondary Endpoints
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Day up to Day 236 post first vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Placebo Vaccine GroupPLACEBO_COMPARATORParticipants will receive a dose of vaccine diluent (placebo) on Days 0, 28 and 56, respectively.
Low Dose Vaccine GroupEXPERIMENTALParticipants will receive a dose of vaccine containing of 2 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
Medium dose vaccine groupEXPERIMENTALParticipants will receive a dose of vaccine containing of 10 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
High dose vaccine groupEXPERIMENTALParticipants will receive a dose of vaccine containing of 50 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
Interventions
NameTypeDescription
Vaccine diluent buffer (Placebo)BIOLOGICAL0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
C. difficile toxoid vaccine (2 µg)BIOLOGICAL0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
C. difficile toxoid vaccine (10 µg)BIOLOGICAL0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
C. difficile toxoid vaccine (50 µg)BIOLOGICAL0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
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Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Adult males or females, \> or = 65 years * In good general health * Clinical lab tests within normal range * Females must be post-menopausal * Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days af...

Countries:United States
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