Clinical trial NCT01178346: Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies
Official title: Health-Related Quality-of-Life and Health-Care Resource Utilization Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: Pharmacoeconomic
Quality of Life
Health Outcomes
Smoking
NicVAX
Smoking vaccine
Smoking cessation
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2010-08-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period.
timeFrame: one year
Secondary outcomes:
measure: To estimate utility scores for use in further health-economic models.
timeFrame: one year
measure: To evaluate health care resource utilization.
timeFrame: one year
Other outcomes:
Locations:
city: Tucson
country: United States
facility: NicVAX Investigator
state: Arizona
city: Encino
country: United States
facility: NicVAX Investigator
state: California
city: Los Alamitos
country: United States
facility: NicVAX Investigator
state: California
city: Newport Beach
country: United States
facility: NicVAX
state: California
city: San Diego
country: United States
facility: NicVAX Investigator
state: California
city: Denver
country: United States
facility: NicVAX Investigator
state: Colorado
city: Brooksville
country: United States
facility: NicVAX Investigator
state: Florida
city: Orlando
country: United States
facility: NicVAX Investigator
state: Florida
city: St. Petersburg
country: United States
facility: NicVAX Investigator
state: Florida
city: Tampa
country: United States
facility: NicVAX Investigator
state: Florida
city: Boise
country: United States
facility: NicVAX Investigator
state: Idaho
city: Indianapolis
country: United States
facility: NicVAX
state: Indiana
city: Metarie
country: United States
facility: NicVAX Investigator
state: Louisiana
city: Baltimore
country: United States
facility: NicVAX Investigator
state: Maryland
city: Minneapolis
country: United States
facility: NicVAX Investigator
state: Minnesota
city: Rochester
country: United States
facility: NicVAX Investigator
state: Minnesota
city: Omaha
country: United States
facility: NicVAX Investigator
state: Nebraska
city: Buffalo
country: United States
facility: NicVAX Investigator
state: New York
city: Cincinnati
country: United States
facility: NicVAX Investigator
state: Ohio
city: Mt Pleasant
country: United States
facility: NicVAX Investigator
state: South Carolina
city: Nashville
country: United States
facility: NicVAX Investigator
state: Tennessee
city: Salt Lake City
country: United States
facility: NicVAX Investigator
state: Utah
city: Salt Lake City
country: United States
facility: NicVAX Investigator
state: Utah
city: Seattle
country: United States
facility: NicVAX Investigator
state: Washington
city: Madison
country: United States
facility: NicVAX Investigator
state: Wisconsin
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Medical Monitor
role: STUDY_DIRECTOR
References: