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MnB rLP2086

Phase 1

Meningitis, Meningococcal | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Dec 5, 2007

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 Enrollment108
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00297687Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy AdultsPHASE1 COMPLETED 108 — — Mar 1, 2006Mar 1, 2007Dec 5, 20073 Australia
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Study Endpoints
Primary Endpoints
Local & systemic safety throughout the trial
Secondary Endpoints
Evidence of an immune response 1 month after dose 2 & 1 month after dose 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
MnB rLP2086BIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 25 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy 18-25 year olds Exclusion Criteria: * Prior history of vaccination with any meningococcal vaccine * Prior history of any invasive meningococcal disease

Countries:Australia
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