Recent Updates
Recently added Catalysts

Clostridium difficile vaccine

Phase 1

Clostridium Infections | Monoclonal antibody | Other |Sanofi|Last Updated: Sep 14, 2012

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00127803Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult VolunteersPHASE1 COMPLETED 50 — — Jul 1, 2005Mar 1, 2006Sep 14, 2012 - —
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.
Day 0 and up to 7 days post each vaccination
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 With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Days 28, 56, 70, and 236 Post First Vaccination
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants will receive a dose of vaccine diluent (placebo) on Days 0, 28, and 56, respectively.
Low dose vaccineEXPERIMENTALParticipants will receive a 2 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively.
Medium dose vaccineEXPERIMENTALParticipants will receive a 10 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively
High dose vaccineEXPERIMENTALParticipants will receive a 50 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively
Interventions
NameTypeDescription
Placebo (vaccine diluent)BIOLOGICAL0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.
Clostridium difficile vaccineBIOLOGICAL0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Adult males or females, 18-55 years (inclusive) * In good general health * Clinical lab tests within normal range * Non-pregnant female subjects * Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 day...

Unlock Eligibility Criteria