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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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