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REPEVAX after REVAXIS

Phase 3

Undisclosed | Monoclonal antibody | Other |Sanofi|Trials 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

REPEVAX after REVAXIS clinical trials

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 after REVAXIS?

REPEVAX after REVAXIS refers to a sequential vaccination strategy in which the REPEVAX vaccine is given one month after the REVAXIS vaccine. It was studied in healthy adults aged 18 years and older in France. Sanofi is the developer.

Who makes REPEVAX after REVAXIS?

Sanofi, which trades under the ticker SNY, is the developer of the REPEVAX after REVAXIS sequential vaccination strategy. Sanofi is the sponsor behind the clinical program evaluating REPEVAX administered one month following REVAXIS.

What phase is REPEVAX after REVAXIS in?

REPEVAX after REVAXIS has been evaluated in a Phase 3 clinical trial. The program is not currently listed with active trials; the single Phase 3 study has completed. It remains an investigational sequential vaccination strategy rather than a standalone approved product.

What clinical trials is REPEVAX after REVAXIS in?

REPEVAX after REVAXIS was studied in one Phase 3 trial, NCT00400309, titled Safety of REPEVAX Given One Month After REVAXIS. The completed study enrolled 500 healthy adult volunteers aged 18 years and older in France and used a randomized, double-blind, active-controlled design.

Is REPEVAX after REVAXIS the same as REPEVAX or REVAXIS?

No. REPEVAX after REVAXIS is not a separate product; it describes the sequence of administering REPEVAX one month after REVAXIS. The two vaccines are distinct, and the name refers to the combined sequential schedule studied in the Phase 3 trial.

How was the REPEVAX after REVAXIS trial designed?

The Phase 3 trial NCT00400309 was a randomized, double-blind, active-controlled study of 500 healthy adults aged 18 years and older. Participants received REPEVAX one month after REVAXIS, and the study was conducted in France. The trial has completed.