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Menactra: Meningococcal Polysaccharide Diphtheria Conjugate

Phase 2

Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 14, 2016

Target and mechanism

ModalityMonoclonal antibody

Also known as Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment333

FDA Designations

No designations recorded

Clinical trial landscape

Menactra: Meningococcal Polysaccharide Diphtheria Conjugate · 1 trial · 3 indications

Phase 2 1
NCT00700635Dose Comparison Study of Menactra® in US ChildrenMeningitis
COMPLETED333 Analytics
PHASE2COMPLETED
Dose Comparison Study of Menactra® in US Children
MeningitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
30 days post-vaccination

Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)

Secondary Endpoints

Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
30 days post-vaccination
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
30 days post-vaccination
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
7 days post-vaccination 1
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Menactra® Group 1EXPERIMENTALParticipants aged 2 to \< 4 years
Menactra® Group 2EXPERIMENTALParticipants aged 4 to \< 6 years
Menactra® Group 3ACTIVE_COMPARATORParticipants aged 6 to \< 11 years

Interventions

NameTypeDescription
Menactra®: Meningococcal Polysaccharide Diphtheria ConjugateBIOLOGICAL0.5 mL, 2 doses Intramuscular
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Eligibility Criteria

Age Range2 Years to 10 Years
SexALL
Healthy VolunteersYes
Study Sites15

Inclusion Criteria : * Aged 2 to \< 11 years on the day of inclusion. * Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative. * Subject and parent/legal guardian able to attend all scheduled ...

Countries:United States
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Frequently asked questions about Menactra: Meningococcal Polysaccharide Diphtheria Conjugate

What is Menactra used for?

Menactra is a meningococcal vaccine developed by Sanofi for the prevention of meningitis and meningococcal infection caused by Neisseria meningitidis. It is studied in children and is designed to generate an immune response against meningococcal disease.

Who makes Menactra?

Menactra is made by Sanofi, which trades under the ticker SNY. Sanofi is the developer responsible for the clinical program evaluating Menactra in pediatric populations.

What phase is Menactra in?

Menactra has been evaluated in a Phase 2 clinical trial. The trial, NCT00700635, is completed and enrolled 333 participants. The study was an active-controlled dose comparison conducted in the United States.

What clinical trials is Menactra in?

Menactra has been studied in one completed clinical trial, NCT00700635, titled Dose Comparison Study of Menactra in US Children. The trial enrolled 333 children aged 2 years and older and included healthy volunteers.

Is Menactra the same as Menactra: Meningococcal Polysaccharide Diphtheria Conjugate?

Yes, Menactra and Menactra: Meningococcal Polysaccharide Diphtheria Conjugate refer to the same product. The full name describes the vaccine composition, and Menactra is the shorter brand name used in prescribing and research.