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Meningococcal C

Phase 2

Meningitis, Meningococcal | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Feb 21, 2013

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00314041Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in InfantsPHASE2 COMPLETED 240 — — Jun 1, 1997Apr 1, 1998Feb 21, 2013 - —
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Study Endpoints
Primary Endpoints
Antibody responses to MnCC and concomitant vaccines
Secondary Endpoints
Safety and reactogenicity
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Meningococcal CBIOLOGICAL -
DTP/HibBIOLOGICAL -
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Eligibility Criteria
Age Range7 Weeks — 10 Weeks
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy infants 7-10 weeks of age eligible to receive routine immunization

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