Recent Updates
Recently added Catalysts

REPEVAX

Phase 3

Healthy | Monoclonal antibody | Other |Sanofi|Last Updated: Sep 11, 2017

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00928785Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy AdultsPHASE3 COMPLETED 52Jul 1, 2009Dec 1, 2009Sep 11, 20179 France, Germany
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL)
10 days
Secondary Endpoints
Geometric Mean Titre (GMT) for tetanus antibodies in both groups
Day 0, Day 1 and Day 28
The anti-tetanus seroprotection rate (antibody titre ≥ 0.1 IU/mL in ELISA)
Day 28
Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events
D0 to Day 7
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
REPEVAXEXPERIMENTAL -
Monovalent tetanus vaccineACTIVE_COMPARATOR -
Interventions
NameTypeDescription
REPEVAXBIOLOGICAL1 dose of 0.5 mL at Day 0
Monovalent Tetanus vaccineBIOLOGICAL1 dose of 0.5 mL at Day 0
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites9

Inclusion Criteria: * Healthy adults aged ≥18 years * Last booster with a T-containing vaccine received 5 to 10 years prior to the administration of the study vaccine (documented by written evidence) * Subject with vaccination history of a primary immunisation with a tetanus, diphtheria and poliomy...

Countries:FranceGermany
Unlock Eligibility Criteria