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Haemophilus Influenzae Type b vaccine

Phase 2

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

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment103
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00771849Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in ChildrenPHASE2 COMPLETED 103Aug 1, 2003May 1, 2004Apr 14, 20162 United Kingdom
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Study Endpoints
Primary Endpoints
Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Day 0 (before) and 28 days post-vaccination
Secondary Endpoints
Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.
28 days post-vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Menactra® Vaccine GroupEXPERIMENTALParticipants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine
Hiberix® Vaccine GroupACTIVE_COMPARATORParticipants receiving Haemophilus Influenzae Type b (Hib) vaccine
Interventions
NameTypeDescription
Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBIOLOGICAL0.5 mL, Intramuscular
Haemophilus Influenzae Type b (Hib) vaccineBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria
Age Range2 Years — 4 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria : * Participant is healthy, as determined by medical history and physical examination. * Participant is 2 years to \< 5 years of age at the time of vaccination. * At least one year from primary vaccination with a monovalent meningococcal C conjugate vaccine has elapsed. * Parent/...

Countries:United Kingdom
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