NCT01178346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

August 5, 2010

Last Update Submit

May 8, 2012

Conditions

Smoking Cessation

Keywords

PharmacoeconomicQuality of LifeHealth OutcomesSmokingNicVAXSmoking vaccineSmoking cessation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

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

    one year

  • To evaluate health care resource utilization.

    one year

Study Arms (2)

NicVAX

EXPERIMENTAL

Experimental vaccine

Biological: NicVAX vaccine

Placebo

PLACEBO COMPARATOR

Placebo vaccine

Biological: Placebo

Interventions

NicVAX vaccineBIOLOGICAL

NicVAX vaccine given 6 times over 6 months

NicVAX
PlaceboBIOLOGICAL

Placebo vaccine given 6 times over 6 months

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects who are unable to complete a HRQoL questionnaire because of inability to understand the language or due to mental impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

NicVAX Investigator

Tucson, Arizona, 85724, United States

Location

NicVAX Investigator

Encino, California, 91316, United States

Location

NicVAX Investigator

Los Alamitos, California, 90720, United States

Location

NicVAX

Newport Beach, California, 92660, United States

Location

NicVAX Investigator

San Diego, California, 92108, United States

Location

NicVAX Investigator

Denver, Colorado, 80204, United States

Location

NicVAX Investigator

Brooksville, Florida, 34601, United States

Location

NicVAX Investigator

Orlando, Florida, 32806, United States

Location

NicVAX Investigator

St. Petersburg, Florida, 33709, United States

Location

NicVAX Investigator

Tampa, Florida, 33606, United States

Location

NicVAX Investigator

Boise, Idaho, 83704, United States

Location

NicVAX

Indianapolis, Indiana, 46202, United States

Location

NicVAX Investigator

Metarie, Louisiana, 700006, United States

Location

NicVAX Investigator

Baltimore, Maryland, 21224, United States

Location

NicVAX Investigator

Minneapolis, Minnesota, 55414, United States

Location

NicVAX Investigator

Rochester, Minnesota, 55905, United States

Location

NicVAX Investigator

Omaha, Nebraska, 68134, United States

Location

NicVAX Investigator

Buffalo, New York, 14263, United States

Location

NicVAX Investigator

Cincinnati, Ohio, 45237, United States

Location

NicVAX Investigator

Mt. Pleasant, South Carolina, 29464, United States

Location

NicVAX Investigator

Nashville, Tennessee, 37203, United States

Location

NicVAX Investigator

Salt Lake City, Utah, 84020, United States

Location

NicVAX Investigator

Salt Lake City, Utah, 84107, United States

Location

NicVAX Investigator

Seattle, Washington, 98104, United States

Location

NicVAX Investigator

Madison, Wisconsin, 53711, United States

Location

MeSH Terms

Conditions

Smoking CessationSmoking

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Medical Monitor

    Nabi Biopharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 10, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

May 9, 2012

Record last verified: 2012-05

Locations

US(25)