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Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

Phase 2

Diphtheria | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 14, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment460

FDA Designations

No designations recorded

Clinical trial landscape

Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC · 1 trial · 5 indications

Phase 2 1
NCT00362427Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®Diphtheria
COMPLETED460 Analytics
PHASE2COMPLETED
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
Diphtheria
NCT00362427460
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Study Endpoints

Primary Endpoints

To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar
14 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Group CACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPCBIOLOGICAL0.5 mL, 4 doses, IM
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Eligibility Criteria

Age Range42 Days to 89 Days
SexALL
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: * Infants aged 42 to 89 days inclusive on the day of inclusion. * Born at full term of pregnancy (\>37 weeks). * Informed consent form signed by the parent(s) or legally authorized representative. * Able to attend all scheduled visits and to comply with the study procedures. * P...

Countries:Canada
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