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NicVAX vaccine

Phase 3

Smoking Cessation | Monoclonal antibody | Other |GSK plc|Last Updated: May 9, 2012

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
Double-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01178346Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 StudiesPHASE3 COMPLETED 500 — — Jul 1, 2010Nov 1, 2011May 9, 201225 United States
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Study Endpoints
Primary Endpoints
To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period.
one year

QoL and health utilization questionnaires will be used to measure this outcome.

Secondary Endpoints
To estimate utility scores for use in further health-economic models.
one year
To evaluate health care resource utilization.
one year
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
NicVAXEXPERIMENTALExperimental vaccine
PlaceboPLACEBO_COMPARATORPlacebo vaccine
Interventions
NameTypeDescription
NicVAX vaccineBIOLOGICALNicVAX vaccine given 6 times over 6 months
PlaceboBIOLOGICALPlacebo vaccine given 6 times over 6 months
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Subjects who are eligible for randomization or have not reached Week 12 in Nabi-4514 or Nabi-4515 studies. * Subjects who agree to participate in health-related quality of life study. Exclusion Criteria: * Subjects who are unable to complete a HRQoL questionnaire because of ...

Countries:United States
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