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DT5aP-IPV-Hib 5-component Pertussis vaccine

Phase 3

Pertussis | Vaccine | Infectious Disease |Sanofi|Trials Updated: Jan 7, 2015

DT5aP-IPV-Hib 5-component Pertussis vaccine development status

Highest phase Phase 3
Registered trials 4 across 2 sponsors since Feb 2006

DT5aP-IPV-Hib 5-component Pertussis vaccine target and mechanism

ModalityVaccine

Also known as Pediacel™

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment807

FDA Designations

No designations recorded

DT5aP-IPV-Hib 5-component Pertussis vaccine clinical trials

DT5aP-IPV-Hib 5-component Pertussis vaccine · 1 trial · 5 indications

Phase 3 1
NCT00287092Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in InfantsPertussis
COMPLETED807 Analytics
PHASE3COMPLETED
Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants
PertussisUnlock trial analytics

Study Endpoints

Primary Endpoints

To provide information concerning the immunogenicity of PEDIACEL® Vaccine.
1 Month post-dose 3

Secondary Endpoints

To provide information concerning the safety after administration of PEDIACEL® Vaccine
Entire study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALParticipants will receive PEDIACEL vaccine
Group 2ACTIVE_COMPARATORParticipants will receive Infanrix-IPV+Hib vaccines

Interventions

NameTypeDescription
DT5aP-IPV-Hib 5-component Pertussis vaccineBIOLOGICAL0.5 mL, IM
Infanrix® -IPV+HibBIOLOGICAL0.5 mL, IM
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Eligibility Criteria

Age Range80 Days to 120 Days
SexALL
Healthy VolunteersYes
Study Sites14

Inclusion Criteria: * Infants aged 80 to 120 days inclusive on the day of inclusion. * Born at full term of pregnancy (\> 37 weeks) * Informed consent form signed by the parent(s) or other legal representative according to local regulations * Parent(s) or legal representative able to attend all sch...

Countries:FinlandSweden
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Frequently asked questions about DT5aP-IPV-Hib 5-component Pertussis vaccine

What is DT5aP-IPV-Hib 5-component Pertussis vaccine?

DT5aP-IPV-Hib is a combination vaccine developed by Sanofi that is designed to protect against pertussis along with diphtheria, tetanus, poliomyelitis, and Haemophilus influenzae type b. It is a five-component acellular pertussis vaccine intended for use in infants.

What is DT5aP-IPV-Hib 5-component Pertussis vaccine used for?

It is used for immunization against pertussis, diphtheria, tetanus, poliomyelitis, and Haemophilus influenzae type b disease. The Phase 3 trial studied it in infants from 80 days of age, given as a three-dose schedule.

Who makes DT5aP-IPV-Hib 5-component Pertussis vaccine?

Sanofi develops DT5aP-IPV-Hib, the five-component pertussis combination vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY.

What phase is DT5aP-IPV-Hib 5-component Pertussis vaccine in?

DT5aP-IPV-Hib is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active.

What clinical trials is DT5aP-IPV-Hib 5-component Pertussis vaccine in?

The vaccine has been studied in the completed Phase 3 trial NCT00287092, which compared Pediacel and Infanrix IPV+Hib given in a three-dose schedule in infants. The randomized, double-blind, active-controlled trial enrolled 807 healthy infants in Finland and Sweden.