Recent Updates
Recently added Catalysts

C. difficile vaccine

Phase 1

Clostridium Difficile Associated Disease | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Mar 6, 2014

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment192
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01706367Evaluation of a 3-dose Vaccination Regimen With One of Three Ascending Dose Levels of Clostridium Difficile Vaccine With or Without Adjuvant in Healthy Adults Aged 50 to 85 YearsPHASE1 COMPLETED 192 — — Sep 1, 2012Jan 1, 2014Mar 6, 20144 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on eDiaries for 7 days following each vaccination.
7 days
Number of subjects reporting systemic reactions (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on eDiaries for 7 days following each vaccination.
7 days
Number of subjects reporting AEs from day 1 (at the time of vaccination) up to 28 days post Dose 3 (visit 9, month 7) and SAEs throughout the study period.
7 months (AEs) 12 months (SAEs)
Number of subjects with abnormal hematology and blood chemistry laboratory assessments after each vaccination dose.
Day 3, Day 14, Month 1, Day 37, Month 6, Day 187
Secondary Endpoints
Neutralizing antibody levels at Month 2.
Month 2
Neutralizing antibody levels after each vaccination dose.
Baseline, Day 14, Month 1, Day 37, Month 6, Day 187, Month 7
Number of subjects in each treatment group with 4 and higher fold-rises in neutralizing antibody levels after each vaccination dose.
Baseline, Day 14, Month 1, Day 37, Month 2, Month 6, Day 187, Month 7
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Low dose C diff vaccineEXPERIMENTAL -
Low dose C diff vaccine + adjuvantEXPERIMENTAL -
Mid dose C diff vaccineEXPERIMENTAL -
Mid dose C diff vaccine + adjuvantEXPERIMENTAL -
High dose C diff vaccineEXPERIMENTAL -
High dose C diff vaccine + adjuvantEXPERIMENTAL -
Interventions
NameTypeDescription
C. difficile vaccineBIOLOGICAL0.5 mL IM injection
C. difficile vaccine +adjuvantBIOLOGICAL0.5 mL IM injection
Unlock Study Design Details
Eligibility Criteria
Age Range50 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document. 2. Healthy male and female adults aged 50 to 85 years at enrollment as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subject...

Countries:United States
Unlock Eligibility Criteria