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Concomitant administration

Phase 3

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

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment954
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01249183Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years OldPHASE3 COMPLETED 954Oct 1, 2010Sep 1, 2011Sep 11, 201720 France, Germany
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Study Endpoints
Primary Endpoints
Diphtheria seroprotection rate
28 to 35 days after vaccine administration
Tetanus seroprotection rate
28 to 35 days after vaccine administration
Polio seroprotection rate
28 to 35 days after vaccine administration
Pertussis antibody titre
28 to 35 days after vaccine administration
Flu geometric mean of titres ratio
28 to 35 days after vaccine administration
Secondary Endpoints
Solicited injection-site reactions, solicited systemic adverse reactions
From Day 0 to Day 7 following REPEVAX vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination
Number and proportion of Serious adverse events
From the first visit to the last visit of the subject
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1- VAXIGRIP and REPEVAX concomitantlyEXPERIMENTAL -
2-REPEVAX 28 days after VAXIGRIPACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Concomitant administrationBIOLOGICAL1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm)
Separate administrationBIOLOGICAL1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later
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Eligibility Criteria
Age Range60 Years — 99 Years
SexALL
Healthy VolunteersYes
Study Sites20

Inclusion Criteria: * Adults aged ≥60 years * At least one documented booster dose with a tetanus- and diphtheria-containing vaccine between 5 and 15 years * No influenza vaccine administered during the last 6 months Exclusion Criteria: * Receipt of a booster dose with a tetanus or diphtheria- or...

Countries:FranceGermany
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