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

Condition(s) targeted: Smoking Cessation

Intervention: NicVAX vaccine (Biological); Placebo (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Nabi Biopharmaceuticals

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Nabi Biopharmaceuticals

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.

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

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

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

Secondary outcome:

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

To evaluate health care resource utilization.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

NicVAX Investigator, Tucson, Arizona 85724, United States

NicVAX Investigator, Encino, California 91316, United States

NicVAX Investigator, Los Alamitos, California 90720, United States

NicVAX, Newport Beach, California 92660, United States

NicVAX Investigator, San Diego, California 92108, United States

NicVAX Investigator, Denver, Colorado 80204, United States

NicVAX Investigator, Brooksville, Florida 34601, United States

NicVAX Investigator, Orlando, Florida 32806, United States

NicVAX Investigator, St. Petersburg, Florida 33709, United States

NicVAX Investigator, Tampa, Florida 33606, United States

NicVAX Investigator, Boise, Idaho 83704, United States

NicVAX, Indianapolis, Indiana 46202, United States

NicVAX Investigator, Metarie, Louisiana 700006, United States

NicVAX Investigator, Baltimore, Maryland 21224, United States

NicVAX Investigator, Minneapolis, Minnesota 55414, United States

NicVAX Investigator, Rochester, Minnesota 55905, United States

NicVAX Investigator, Omaha, Nebraska 68134, United States

NicVAX Investigator, Buffalo, New York 14263, United States

NicVAX Investigator, Cincinnati, Ohio 45237, United States

NicVAX Investigator, Mt Pleasant, South Carolina 29464, United States

NicVAX Investigator, Nashville, Tennessee 37203, United States

NicVAX Investigator, Salt Lake City, Utah 84020, United States

NicVAX Investigator, Salt Lake City, Utah 84107, United States

NicVAX Investigator, Seattle, Washington 98104, United States

NicVAX Investigator, Madison, Wisconsin 53711, United States

Starting date: July 2010
Last updated: May 8, 2012