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meningococcal B rLP2086 vaccine candidate

Phase 1

Meningitis, Meningococcal | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Aug 23, 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
RandomizedUNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00780806Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In AdultsPHASE1 COMPLETED 60Oct 1, 2008May 1, 2010Aug 23, 20113 Australia
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Study Endpoints
Primary Endpoints
Safety of 3 doses of MnB rLP2086 vaccine candidate assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccination; evaluation of occurrence of AE and SAE during the duration of study
Up to 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
1EXPERIMENTALImmunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months
Interventions
NameTypeDescription
meningococcal B rLP2086 vaccine candidateBIOLOGICALvaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months
Blood drawPROCEDUREBlood draw
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy male or female subject between the ages of \>=18 and \<=40 years * Negative urine pregnancy test for all female subjects of childbearing potential prior to test article administration and at the completion of the study. * All female or male subjects who are biologicall...

Countries:Australia
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