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Concomitant administration

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |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 Enrollment954

FDA Designations

No designations recorded

Clinical trial landscape

Concomitant administration · 1 trial · 4 indications

Phase 3 1
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 OldDiphtheria
COMPLETED954 Analytics
PHASE3COMPLETED
Safety 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 Old
Diphtheria
NCT01249183954
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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 to 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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Frequently asked questions about Concomitant administration

What is Concomitant administration used for in Diphtheria?

Concomitant administration is a Phase 3 investigational regimen being studied for use in diphtheria, as well as tetanus, pertussis, and poliomyelitis. It involves giving the diphtheria, tetanus, pertussis, and poliomyelitis vaccine (REPEVAX) together with the influenza vaccine (VAXIGRIP) in adults aged 60 years and older.

Who makes Concomitant administration?

Concomitant administration is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The company is conducting clinical research to evaluate the safety and immunogenicity of this vaccine administration regimen.

What phase is Concomitant administration in?

Concomitant administration is in Phase 3 clinical development. It is an investigational regimen and has not been approved by regulatory authorities. One Phase 3 trial has been completed to evaluate its safety and immunogenicity in older adults.

What clinical trials is Concomitant administration in?

Concomitant administration has one completed Phase 3 clinical trial, identified as NCT01249183. This study evaluated the safety and immunogenicity of concomitant versus non-concomitant administration of REPEVAX and VAXIGRIP in 954 subjects aged 60 years and older in France and Germany.

Is Concomitant administration the same as REPEVAX or VAXIGRIP?

Concomitant administration is not a drug itself but a regimen that involves giving two vaccines together: REPEVAX, a diphtheria, tetanus, pertussis, and poliomyelitis vaccine, and VAXIGRIP, an influenza vaccine. The clinical trial compares giving these vaccines at the same time versus at different times.