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Meningococcal Polysaccharide Diphtheria Protein Conjugate

Phase 2

Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Feb 14, 2014

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment378

FDA Designations

No designations recorded

Clinical trial landscape

Meningococcal Polysaccharide Diphtheria Protein Conjugate · 1 trial · 2 indications

Phase 2 1
NCT00643916Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of AgeMeningitis
COMPLETED378 Analytics
PHASE2COMPLETED
Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Vaccinated at Age 9 and 12 MonthsEXPERIMENTALParticipants received Menactra® vaccine at 9 and 12 Months of age
Vaccinated at Age 9 and 15 MonthsEXPERIMENTALParticipants received Menactra® vaccine at 9 and 15 Months of age
Vaccinated at Age 12 and 15 MonthsEXPERIMENTALParticipants received Menactra® vaccine at Age 12 and 12 Months of age
Vaccinated at Age 15 MonthsEXPERIMENTALParticipants received Menactra® vaccine at 15 Months of age
Vaccinated at Age 18 MonthsEXPERIMENTALParticipants received Menactra® vaccine at 18 Months of age
Vaccinated at Age 3 Years to <6 YearsACTIVE_COMPARATORParticipants received Menomune® vaccine at Age 3 years to \<6 years of age

Interventions

NameTypeDescription
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)BIOLOGICAL0.5 mL, Intramuscular (at age 9 and 12 months)
A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)BIOLOGICAL0.5 mL, Subcutaneous (at 3 years to \<6 years of age)
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Eligibility Criteria

Age Range9 Months to 5 Years
SexALL
Healthy VolunteersYes
Study Sites14

Inclusion Criteria : * Aged either 9, 12, 15 or 18 months of age or 3 to \< 6 years of age on the day of inclusion. * Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian * Able to attend all scheduled visits and to c...

Countries:United States
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