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

Nabi Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Biological: Placebo; Biological: NicVAX vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01178346

Nabi-4519

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups, including a placebo group

NicVAX

Experimental group

Description:

Experimental vaccine

Treatment:

Biological: NicVAX vaccine

Placebo

Placebo Comparator group

Description:

Placebo vaccine

Treatment:

Biological: Placebo