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Meningococcal

Phase 2

Infections, Meningococcal | Monoclonal antibody | Other |GSK plc|Last Updated: Sep 21, 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 Trials3
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00126945Evaluate 4 Different Formulations of Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 YrsPHASE2 COMPLETED 125Aug 1, 2005Oct 1, 2005Sep 21, 20161 Denmark
NCT00196963Evaluate 4 Different Formulations of Meningococcal Serogroups A, C, W-135, Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 YrsPHASE2 COMPLETED 125Mar 1, 2005Jul 1, 2005Sep 21, 20161 Belgium
NCT00196950Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 YearsPHASE2 COMPLETED 50Sep 1, 2003Oct 1, 2003Sep 7, 20161 Belgium
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Study Endpoints
Primary Endpoints
Percentage of serum bactericidal activity SBA-MenA, SBA-MenC, SBA-MenW-135 and SBA-MenY responders (i.e. 4-fold increase in serum bactericidal antibody [SBA] titre from pre to post vaccination) at 1 month after the first vaccine dose
% of serum bactericidal activity SBA-MenA, SBA-MenC, SBA-MenW-135 and SBA-MenY responders (i.e.>= 4-fold increase in SBA titre from pre to post vaccination) at 1 month after the vaccine dose.
The occurrence of any grade 3 solicited symptoms within 8 days (day 0-7) following vaccination.
Secondary Endpoints
Antibodies to MenACWY before + 1 m after dose 1, 12 m after dose 1 in control + with selected vaccine groups, 1 m after booster
Solicited, unsolicited symptoms after each dose and serious adverse events (SAEs)
Prophylaxis meningococcal serogroups A, C, W-135, Y disease
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Meningococcal VaccineBIOLOGICAL -
Meningococcal (vaccine)BIOLOGICAL -
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Eligibility Criteria
Age Range15 Years — 19 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination. * Subject with previously completed routine childhood vaccinations to the best of his/her knowledge or his/her parents'/guardians' knowledge. * Female subjects should be of non-ch...

Countries:DenmarkBelgium
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