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Meningococcal Conjugate

Phase 3

Meningitis | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 5, 2014

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_CONTROLLED
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00901940Understanding the Immune Response to Meningitis VaccinesPHASE3 COMPLETED 150Jun 1, 2009Oct 1, 2010Dec 5, 20141 United Kingdom
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Study Endpoints
Primary Endpoints
The primary endpoint will be whether the SBA GMT at day 7 following MenACWY is ≥ 30% greater than that observed at day 7 following MenACWY PS.
Day 7
Secondary Endpoints
The measurement of meningococcal serogroup C SBAs (using human complement) at day 7 following the initial immunisation with MenACWY and MenACWY PS.
Day 7
The measurement of meningococcal serogroup A and C specific SBAs (using human complement) at day 28 following the initial immunisation with MenACWY and MenACWY PS, and at day 7 and day 28 following the 'follow up' immunisation with MenACWY.
Day 7-28
Meningococcal serogroup W-135 and Y SBAs will also be performed on a subset of samples obtained at the above timepoints.
Day 7-28
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
MenACWY Plain Polysaccharide (ACWY Vax)ACTIVE_COMPARATORThe MenACWY Plain Polysaccharide Vaccine, which is already licensed and is used as a travel vaccine, is known as the MenACWY plain polysaccharide (ACWY Vax). Participants in this arm will receive 1 dose of the MenACWY plain polysaccharide (ACWY Vax) and 1 dose of the MenACWY conjugate (MenACWY).
MenACWY conjugateACTIVE_COMPARATORThe MenACWY conjugate vaccine was licensed in the UK in March 2010, and is known as the MenACWY conjugate vaccine (Menveo). Participants in this arm will receive 2 doses of the MenACWY conjugate vaccine.
Interventions
NameTypeDescription
Meningococcal (Groups A, C, Y and W-135) ConjugateBIOLOGICAL2 x 0.5 mL dose
Meningococcal polysaccharide A, C, Y and W135 and MenveoBIOLOGICAL1 x 0.5 mL dose of ACWY Vax, 1 x 0.5 mL dose of Menveo
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant is willing and able to give informed consent for participation after the nature of the study has been explained * Male or Female, aged 18- 70 years inclusive * In good health as determined by: * Medical history * History-directed physical examination * Clini...

Countries:United Kingdom
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