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NicVAX vaccine

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

Double-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Clinical trial landscape

NicVAX vaccine · 1 trial · 1 indication

Phase 3 1
NCT01178346Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 StudiesSmoking Cessation
COMPLETED500 Analytics
PHASE3COMPLETED
Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies
Smoking CessationUnlock trial analytics

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 to 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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Frequently asked questions about NicVAX vaccine

What is NicVAX vaccine used for?

NicVAX vaccine is an investigational monoclonal antibody being developed for smoking cessation. It is designed to help people quit smoking, and it is being studied in the context of psychiatric care. The drug is still in clinical development and has not been approved by the FDA.

Who makes NicVAX vaccine?

NicVAX vaccine is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy for smoking cessation.

What phase is NicVAX vaccine in?

NicVAX vaccine is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is not currently in active trials.

What clinical trials is NicVAX vaccine in?

NicVAX vaccine has one completed Phase 3 clinical trial, identified as NCT01178346. This trial, titled 'Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies,' enrolled 500 participants in the United States and focused on smoking cessation.

Is NicVAX vaccine a monoclonal antibody?

Yes, NicVAX vaccine is classified as a monoclonal antibody. It is being investigated as a potential treatment to aid smoking cessation, and it is administered as a vaccine to elicit an immune response.