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DTaP-IPV combined vaccine

Phase 3

Pertussis | Vaccine | Infectious Disease |Sanofi|Trials Updated: Apr 16, 2012

DTaP-IPV combined vaccine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Apr 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment442

FDA Designations

No designations recorded

DTaP-IPV combined vaccine clinical trials

DTaP-IPV combined vaccine · 1 trial · 4 indications

Phase 3 1
NCT00319852Immunogenicity and Safety of Tetraxim Versus Local DTP + IPVPertussis
COMPLETED442 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
PertussisUnlock trial analytics

Study Endpoints

Primary Endpoints

To provide information concerning the immunogenicity of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines.
1 month post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
DTaP-IPV combined vaccineBIOLOGICAL0.5 mL, IM
DTaP vaccineBIOLOGICAL0.5 mL, IM
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Eligibility Criteria

Age Range56 Days to 70 Days
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Aged 56 to 70 days inclusive on the day of inclusion * Born at full term pregnancy (\>37 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by the parent(s) or other legal representative * Able to attend all scheduled visits and to comply with all trial procedu...

Countries:South Korea
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Frequently asked questions about DTaP-IPV combined vaccine

What is the DTaP-IPV combined vaccine?

The DTaP-IPV combined vaccine is a vaccine developed by Sanofi that combines protection against diphtheria, tetanus, pertussis, and poliomyelitis in a single product. It is given to infants and young children, with trial enrollment starting at 56 days of age. It is being studied for use in infectious disease prevention.

What is the DTaP-IPV combined vaccine used for?

The DTaP-IPV combined vaccine is used to protect against pertussis, diphtheria, tetanus, and poliomyelitis. Sanofi is developing it as a single combined immunization for these four diseases. The Phase 3 trial enrolled healthy infants from 56 days of age in South Korea.

Who makes the DTaP-IPV combined vaccine?

Sanofi makes the DTaP-IPV combined vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is the developer of this combined pediatric vaccine candidate.

What phase is the DTaP-IPV combined vaccine in?

The DTaP-IPV combined vaccine is in Phase 3 clinical development. It is an investigational vaccine and is not described as approved. One Phase 3 trial has been completed, and no trials are currently active.

What clinical trials is the DTaP-IPV combined vaccine in?

The DTaP-IPV combined vaccine has been studied in one completed Phase 3 trial, NCT00319852, titled Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV. That randomized, active-controlled trial enrolled 442 healthy participants in South Korea, with ages starting at 56 days.