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Infanrix-IPV+Hib and Prevenar

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jun 3, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment588

FDA Designations

No designations recorded

Clinical trial landscape

Infanrix-IPV+Hib and Prevenar · 1 trial · 5 indications

Phase 3 1
NCT00343421Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and ToddlersDiphtheria
COMPLETED588 Analytics
PHASE3COMPLETED
Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
Diphtheria
NCT00343421588
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Study Endpoints

Primary Endpoints

To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib
1 month post-vaccination

Secondary Endpoints

To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib
Entire study
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALPEDIACEL co-administered with Prevenar
Group 2ACTIVE_COMPARATORInfanrix-IPV+Hib co-administered with Prevenar

Interventions

NameTypeDescription
PEDIACEL® and Prevenar®BIOLOGICAL0.5 mL each, IM (opposite thigh)
Infanrix®-IPV+Hib and Prevenar®BIOLOGICAL0.5 mL each, IM (opposite thigh)
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Eligibility Criteria

Age Range55 Days to 75 Days
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Infants 55 to 75 days old, inclusive on the day of first vaccination * Born at full term of pregnancy (\> 37 weeks) * Informed consent form signed by the parent(s) or the legal guardian * Parents or the legal guardian able to read and write in the local language * Parent(s) or...

Countries:FrancePoland
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