Skip to main content
OpenTrials
Completed

NCT Number: NCT01178346

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NicVAX Investigator, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NicVAX Vaccine

Biological

NicVAX vaccine given 6 times over 6 months

Placebo

Biological

Placebo vaccine given 6 times over 6 months

Primary outcomes

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

    Time frame: one year

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

Secondary outcomes

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

    Time frame: one year

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

  2. To evaluate health care resource utilization.

    Time frame: one year

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

Sponsors and collaborators

Lead sponsor

Nabi Biopharmaceuticals

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 10, 2010
Registry last updated
May 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.