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Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Phase 2

Meningococcal Meningitis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Aug 24, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment882
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00355121Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®PHASE2 COMPLETED 882 — — Oct 1, 2006Jul 1, 2009Aug 24, 201126 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Day 30 post-vaccination (Visit 1)

Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.

Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Day 30 post-vaccination (Visit 1)

Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)

Secondary Endpoints
Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Day 30 post-vaccination 1
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Day 30 post-vaccination
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
Day 0 through Day 7 post-vaccination at Visit 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALDAPTACEL® + IPOL on Day 0 and Menactra on Day 30
Group 2EXPERIMENTALDAPTACEL® + Menactra® on Day 0 and IPOL on Day 30
Group 3EXPERIMENTALMenactra® + IPOL on Day 0 and DAPTACEL® on Day 30
Interventions
NameTypeDescription
Polysaccharide Diphtheria Toxoid Conjugate VaccineBIOLOGICAL0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
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Eligibility Criteria
Age Range4 Years — 7 Years
SexALL
Healthy VolunteersYes
Study Sites26

Inclusion Criteria: * Healthy, as determined by medical history and physical examination. * Aged 4 to \< 7 years at the time of study vaccination on Day 0. * Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian. * Prev...

Countries:United States
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