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NZ MenB OMV vaccine

Phase 2

Meningococcal Infections | Monoclonal antibody | Other |Novartis AG|Last Updated: Nov 15, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00774384Regulation of Mucosal Immune Response to Systemic MenB VaccinePHASE2 COMPLETED 9 — — Sep 1, 2009Nov 1, 2011Nov 15, 20162 United Kingdom
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Study Endpoints
Primary Endpoints
T-cell proliferation following vaccination and its regulation.
After 2 or 3 doses of vaccine
Secondary Endpoints
Serum bactericidal antibody and OMV ELISA antibody.
After each does of vaccine
Salivary antibody
After each dose of vaccine
B-cell memory
After 2 or 3 doses of vaccine
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORImmunisation with NZ MenB OMV vaccine (NZ98/254)
2NO_INTERVENTIONNo vaccine
Interventions
NameTypeDescription
NZ MenB OMV vaccine (NZ98/254)BIOLOGICAL3 doses by intramuscular injection
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Eligibility Criteria
Age Range16 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * written informed consent and agreement for samples to be sent overseas * adults and adolescents 16-40 years scheduled to undergo routine tonsillectomy * in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgm...

Countries:United Kingdom
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