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REPEVAX after REVAXIS

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Clinical trial landscape

REPEVAX after REVAXIS · 1 trial · 1 indication

Phase 3 1
NCT00400309Safety of REPEVAX® Given One Month After REVAXIS®Healthy Adult
COMPLETED500 Analytics
PHASE3COMPLETED
Safety of REPEVAX® Given One Month After REVAXIS®
Healthy AdultUnlock trial analytics

Study Endpoints

Primary Endpoints

injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine.
7 days

Secondary Endpoints

injection-site adverse reactions and systemic adverse events during the 14 day-safety period post-vaccination with Td-IPV vaccine, TdaP-IPV vaccine and placebo and serious adverse events
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
REPEVAX® after REVAXIS®EXPERIMENTALREVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).
REPEVAX® after PlaceboACTIVE_COMPARATORPlacebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).

Interventions

NameTypeDescription
REPEVAX® after REVAXIS®BIOLOGICALTetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
REPEVAX® after PlaceboBIOLOGICALTetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Healthy adult, with vaccination history (by written evidence) of a minimum of 5 doses of a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the French vaccination calendar at 18 years old, and a maximum of 8 doses. * Last dose of a tetanus and/or diph...

Countries:France
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Frequently asked questions about REPEVAX after REVAXIS

What is REPEVAX used for?

REPEVAX is a vaccine used in healthy adults. It is given one month after REVAXIS to assess safety. The drug is being studied in a Phase 3 clinical trial in France.

Who makes REPEVAX?

REPEVAX is developed by Sanofi, a company traded under the ticker SNY. The drug is currently in Phase 3 clinical development for use in healthy adults.

What phase is REPEVAX in?

REPEVAX is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed.

What clinical trials is REPEVAX in?

REPEVAX has one completed Phase 3 trial, NCT00400309, titled 'Safety of REPEVAX® Given One Month After REVAXIS®'. The trial enrolled 500 healthy adults in France and was randomized, double-blind, and active-controlled.

Is REPEVAX the same as REVAXIS?

No, REPEVAX and REVAXIS are different vaccines. The clinical trial NCT00400309 studies the safety of giving REPEVAX one month after REVAXIS, indicating they are separate products used in sequence.