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Meningococcal Polysaccharide Diphtheria Protein Conjugate

Phase 2

Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Trials 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

Meningococcal Polysaccharide Diphtheria Protein Conjugate clinical trials

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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Frequently asked questions about Meningococcal Polysaccharide Diphtheria Protein Conjugate

What is Meningococcal Polysaccharide Diphtheria Protein Conjugate used for?

Meningococcal Polysaccharide Diphtheria Protein Conjugate is used for the prevention of meningitis and meningococcal infection. It is a vaccine developed by Sanofi. The only clinical trial of this product enrolled toddlers 9 to 18 months of age in the United States.

Who makes Meningococcal Polysaccharide Diphtheria Protein Conjugate?

Meningococcal Polysaccharide Diphtheria Protein Conjugate is made by Sanofi, which trades under the ticker SNY. Sanofi is the developer of this vaccine candidate.

What phase is Meningococcal Polysaccharide Diphtheria Protein Conjugate in?

Meningococcal Polysaccharide Diphtheria Protein Conjugate is in Phase 2 development. It is an investigational product and is not approved. The Phase 2 trial, NCT00643916, has been completed.

What clinical trials is Meningococcal Polysaccharide Diphtheria Protein Conjugate in?

Meningococcal Polysaccharide Diphtheria Protein Conjugate has been studied in one clinical trial, NCT00643916, titled Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age. The Phase 2 trial was completed and enrolled 378 participants in the United States.

Is Meningococcal Polysaccharide Diphtheria Protein Conjugate the same as Menactra?

Yes, Meningococcal Polysaccharide Diphtheria Protein Conjugate is also known as Menactra. Menactra is the brand name for this Sanofi product.