Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies

Nabi Biopharmaceuticals500 enrolled

Overview

The purpose of this study is to look at pharmacoeconomic data for subjects that have received either NicVAX or placebo in the Nabi-4514 or Nabi-4515 studies.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

QUADRUPLE

Enrollment

500

Conditions

Smoking Cessation

Interventions

NicVAX vaccineBIOLOGICAL

NicVAX vaccine given 6 times over 6 months

PlaceboBIOLOGICAL

Placebo vaccine given 6 times over 6 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 inability to understand the language or due to mental impairment.

Locations (25)

NicVAX Investigator

Tucson, Arizona, United States

Outcomes

Primary Outcomes

To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period.

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

Time frame: one year

Secondary Outcomes

To estimate utility scores for use in further health-economic models.

Scores will be computed from QoL questionnaires to measure this outcome.

Time frame: one year

To evaluate health care resource utilization.

Health care visits, medications, hospitalizations and medical procedures will be collected to measure this outcome.

Time frame: one year

Data from ClinicalTrials.gov

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