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DTaP-IPV combined vaccine

Phase 3

Pertussis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 16, 2012

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

Clinical trial landscape

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 DTaP-IPV combined vaccine used for?

DTaP-IPV combined vaccine is used for the prevention of pertussis, diphtheria, poliomyelitis, and tetanus. It is a combination vaccine that provides protection against these infectious diseases. The vaccine is being developed for use in infants and young children, as the clinical trial enrolled participants as young as 56 days old.

Who makes DTaP-IPV combined vaccine?

DTaP-IPV combined vaccine is being developed by Sanofi, a multinational pharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the vaccine's immunogenicity and safety for the prevention of pertussis and other infectious diseases.

What phase is DTaP-IPV combined vaccine in?

DTaP-IPV combined vaccine is currently in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine is being evaluated for its safety and ability to generate an immune response against pertussis, diphtheria, poliomyelitis, and tetanus.

What clinical trials is DTaP-IPV combined vaccine in?

DTaP-IPV combined vaccine has one completed Phase 3 clinical trial registered under NCT00319852. The trial, titled "Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV," enrolled 442 participants in South Korea. The study was active-controlled and evaluated the vaccine's immunogenicity and safety in healthy volunteers.

How does DTaP-IPV combined vaccine work?

DTaP-IPV combined vaccine works by stimulating the immune system to produce antibodies against the bacteria and viruses that cause pertussis, diphtheria, tetanus, and poliomyelitis. It is a combination vaccine that includes components for diphtheria, tetanus, acellular pertussis, and inactivated poliovirus, providing broad protection against these diseases.

Is DTaP-IPV combined vaccine the same as Tetraxim?

Yes, DTaP-IPV combined vaccine is also known as Tetraxim. The clinical trial NCT00319852 compared Tetraxim against a local DTP + IPV vaccine. This combination vaccine is designed to protect against diphtheria, tetanus, pertussis, and poliomyelitis in a single formulation.