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REPEVAX

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

REPEVAX · 1 trial · 1 indication

Phase 3 1
NCT00928785Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy AdultsHealthy
COMPLETED52 Analytics
PHASE3COMPLETED
Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults
Healthy
NCT0092878552
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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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about REPEVAX

What is REPEVAX used for?

REPEVAX is an investigational vaccine being studied for use in healthy adults. It is being evaluated in a Phase 3 clinical trial as a combined Tdap-IPV vaccine, which is intended to protect against tetanus, diphtheria, pertussis, and polio. The drug is still in clinical development and is not yet approved.

Who makes REPEVAX?

REPEVAX is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this vaccine candidate in healthy adult populations.

What phase is REPEVAX in?

REPEVAX is currently in Phase 3 clinical development. It has completed one Phase 3 trial, which involved 52 healthy adult participants. As an investigational drug, REPEVAX has not yet received regulatory approval and remains under evaluation for its intended use.

What clinical trials is REPEVAX in?

REPEVAX has been studied in one completed Phase 3 clinical trial with the identifier NCT00928785. This trial compared a Tdap-IPV combined vaccine with a tetanus monovalent vaccine in healthy adults. The study was conducted in France and Germany and enrolled 52 participants aged 18 years and older.

Is REPEVAX the same as a Tdap-IPV vaccine?

REPEVAX is a combined Tdap-IPV vaccine, meaning it is designed to provide protection against tetanus, diphtheria, pertussis, and polio in a single formulation. In clinical trials, it has been compared against a tetanus monovalent vaccine to assess its immunogenicity and safety profile.