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

Smoking Cessation Clinical Trial

Official title:

Health-Related Quality-of-Life and Health-Care Resource Utilization Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178346
• Other study ID #: Nabi-4519
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2010
• Last updated: May 8, 2012
• Start date: July 2010
• Est. completion date: November 2011

Study information

• Verified date: May 2012
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Biological:
• NicVAX vaccine
NicVAX vaccine given 6 times over 6 months
• Placebo
Placebo vaccine given 6 times over 6 months

Locations

Country	Name	City	State
United States	NicVAX Investigator	Baltimore	Maryland
United States	NicVAX Investigator	Boise	Idaho
United States	NicVAX Investigator	Brooksville	Florida
United States	NicVAX Investigator	Buffalo	New York
United States	NicVAX Investigator	Cincinnati	Ohio
United States	NicVAX Investigator	Denver	Colorado
United States	NicVAX Investigator	Encino	California
United States	NicVAX	Indianapolis	Indiana
United States	NicVAX Investigator	Los Alamitos	California
United States	NicVAX Investigator	Madison	Wisconsin
United States	NicVAX Investigator	Metarie	Louisiana
United States	NicVAX Investigator	Minneapolis	Minnesota
United States	NicVAX Investigator	Mt Pleasant	South Carolina
United States	NicVAX Investigator	Nashville	Tennessee
United States	NicVAX	Newport Beach	California
United States	NicVAX Investigator	Omaha	Nebraska
United States	NicVAX Investigator	Orlando	Florida
United States	NicVAX Investigator	Rochester	Minnesota
United States	NicVAX Investigator	Salt Lake City	Utah
United States	NicVAX Investigator	Salt Lake City	Utah
United States	NicVAX Investigator	San Diego	California
United States	NicVAX Investigator	Seattle	Washington
United States	NicVAX Investigator	St. Petersburg	Florida
United States	NicVAX Investigator	Tampa	Florida
United States	NicVAX Investigator	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year	No
Secondary	To estimate utility scores for use in further health-economic models.	Scores will be computed from QoL questionnaires to measure this outcome.	one year	No
Secondary	To evaluate health care resource utilization.	Health care visits, medications, hospitalizations and medical procedures will be collected to measure this outcome.	one year	Yes