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Meningococcal serogroup B vaccine

Phase 2

Infections, Meningococcal | Monoclonal antibody | Other |GSK plc|Last Updated: Sep 16, 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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment478
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00137917Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 YrsPHASE2 COMPLETED 478 — — Jul 1, 2002Jun 1, 2003Sep 16, 2016 - —
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Study Endpoints
Primary Endpoints
Meningococcal serogroup B (MenB) immune response (i.e. at least a 4-fold increase in serum bactericidal activity [SBA] from pre-vaccination titer) at 1 month postvaccination for each MenB strain assayed
Secondary Endpoints
For each MenB strain assayed, pre and 1m post dose 2 and 3: SBA seropositivity, titer and immune response (post dose 2 only)
After each vaccination: grade 3 and any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30)
Serious adverse events [SAEs] (whole study)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Meningococcal serogroup B vaccineBIOLOGICAL -
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Eligibility Criteria
Age Range12 Years — 18 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination. * Female subjects must be of non-childbearing potential. Exclusion Criteria: * Previous vaccination against or history of meningococcal B or C, or hepatitis A diseas...

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