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DT5aP-IPV-Hib 5-component Pertussis vaccine

Phase 3

Infant | Monoclonal antibody | Other |Sanofi|Last Updated: Jan 7, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment847

FDA Designations

No designations recorded

Clinical trial landscape

DT5aP-IPV-Hib 5-component Pertussis vaccine · 2 trials · 7 indications

Phase 3 2
NCT00355654Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®Infant
COMPLETED847 Analytics
NCT00287092Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in InfantsPertussis
COMPLETED807 Analytics
PHASE3COMPLETED
Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®
Infant
NCT00355654847
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PHASE3COMPLETED
Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants
Pertussis
NCT00287092807
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Study Endpoints

Primary Endpoints

To provide information concerning the safety after administration of PEDIACEL® booster dose
0 to 3 Days post-vaccination
To provide information concerning the immunogenicity of PEDIACEL® Vaccine.
1 Month post-dose 3

Secondary Endpoints

To provide information concerning the safety (as fever rate) after administration of PEDIACEL® Vaccine
4 days post-vaccination
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 with Prevenar at Visit 1 and ENGERIX-B Kinder at Visit 2
Group 2ACTIVE_COMPARATORParticipants will receive Infanrix hexa with Prevenar at Visit 1

Interventions

NameTypeDescription
DT5aP-IPV-Hib 5-component Pertussis vaccineBIOLOGICAL0.5 mL, IM
DT3aP-HBs-IPVBIOLOGICAL0.5 mL, IM
Infanrix® -IPV+HibBIOLOGICAL0.5 mL, IM
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Eligibility Criteria

Age Range11 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites84

Inclusion Criteria: * Toddlers 11-18 months of age (from the 11th month birthday to one day prior to the 19th month birthday) who previously received the primary immunisation series with a hexavalent vaccine (consisting of three doses of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B an...

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

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

DT5aP-IPV-Hib 5-component Pertussis vaccine is used for immunization against pertussis, diphtheria, tetanus, poliomyelitis, and Haemophilus influenzae type b in infants. It is a combination vaccine studied in a 3-dose schedule in infants and as a booster vaccination, with clinical trials conducted in Finland, Sweden, and Germany.

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

Sanofi (ticker: SNY) is developing DT5aP-IPV-Hib 5-component Pertussis vaccine. The vaccine is in Phase 3 clinical development for use in infants against pertussis and other diseases.

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

DT5aP-IPV-Hib 5-component Pertussis vaccine is in Phase 3 clinical development. It is investigational and not yet approved, with completed Phase 3 trials evaluating its safety and immunogenicity in infants.

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

DT5aP-IPV-Hib 5-component Pertussis vaccine has two completed Phase 3 trials: NCT00287092, comparing Pediacel and Infanrix IPV+Hib in a 3-dose schedule in infants, and NCT00355654, comparing booster vaccination with Pediacel to Infanrix Hexa co-administered with Prevenar.

Is DT5aP-IPV-Hib 5-component Pertussis vaccine the same as Pediacel?

DT5aP-IPV-Hib 5-component Pertussis vaccine is referred to as Pediacel in clinical trials. The trials NCT00287092 and NCT00355654 use the brand name Pediacel to describe the vaccine being studied.