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DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Dec 13, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,056

FDA Designations

No designations recorded

Clinical trial landscape

DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine · 1 trial · 4 indications

Phase 3 1
NCT01062477A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy InfantsDiphtheria
COMPLETED1,056 Analytics
PHASE3COMPLETED
A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants
Diphtheria
NCT010624771,056
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Study Endpoints

Primary Endpoints

Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination.
One month post-vaccination

Secondary Endpoints

Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine.
0-7 days post-vaccination and entire study duration
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Study Group 1EXPERIMENTALParticipants will receive ACTACEL vaccine at 2, 3, and 4 months of age.
Study Group 2EXPERIMENTALParticipants will receive ACTACEL vaccine at 3, 4, and 5 months of age.
Study Group 3ACTIVE_COMPARATORParticipants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age.

Interventions

NameTypeDescription
DTaP//PRP-T Combined VaccineBIOLOGICAL0.5 mL, Intramuscular
DTaP Combined Vaccine and PRP-Tetanus Conjugate VaccineBIOLOGICAL0.5 mL, Intramuscular (each vaccine)
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Eligibility Criteria

Age Range60 Days to 89 Days
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria : * Aged 2 months on the day of inclusion * Born at full term pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by the parent(s) or legal representative * Participant and parent/legal representative able to attend all scheduled visits and to compl...

Countries:China
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