Smoking CessationPhase 3NCT01178346

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

A Phase 3 study testing NicVAX vaccine in people with Smoking Cessation, run by Nabi Biopharmaceuticals at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Smoking Cessation
What is being tested?: NicVAX vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 500 participants
Where: 25 sitesUnited States
Study dates: Jul 2010to Nov 2011
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

NicVAX Investigator
Baltimore, Maryland, 21224
NicVAX Investigator
Boise, Idaho, 83704
NicVAX Investigator
Brooksville, Florida, 34601
NicVAX Investigator
Buffalo, New York, 14263
NicVAX Investigator
Cincinnati, Ohio, 45237
NicVAX Investigator
Denver, Colorado, 80204
NicVAX Investigator
Encino, California, 91316
NicVAX
Indianapolis, Indiana, 46202
NicVAX Investigator
Los Alamitos, California, 90720
NicVAX Investigator
Madison, Wisconsin, 53711
NicVAX Investigator
Metarie, Louisiana, 700006
NicVAX Investigator
Minneapolis, Minnesota, 55414
NicVAX Investigator
Mt. Pleasant, South Carolina, 29464
NicVAX Investigator
Nashville, Tennessee, 37203
NicVAX
Newport Beach, California, 92660
NicVAX Investigator
Omaha, Nebraska, 68134
NicVAX Investigator
Orlando, Florida, 32806
NicVAX Investigator
Rochester, Minnesota, 55905
NicVAX Investigator
Salt Lake City, Utah, 84020
NicVAX Investigator
Salt Lake City, Utah, 84107
NicVAX Investigator
San Diego, California, 92108
NicVAX Investigator
Seattle, Washington, 98104
NicVAX Investigator
St. Petersburg, Florida, 33709
NicVAX Investigator
Tampa, Florida, 33606
NicVAX Investigator
Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: Health-Related Quality-of-Life and Health-Care Resource Utilization 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.

Conditions: Smoking Cessation
Being tested: NicVAX vaccine, Placebo
Keywords: Pharmacoeconomic, Quality of Life, Health Outcomes, Smoking, NicVAX, Smoking vaccine, Smoking cessation
Medical subject headings: Smoking Cessation, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NicVAX vaccineBiological
NicVAX vaccine given 6 times over 6 months
PlaceboBiological
Placebo vaccine given 6 times over 6 months

Study groups in NCT01178346
Study group	Role	What they receive
NicVAX	Experimental	Experimental vaccine Receives: Biological: NicVAX vaccine
Placebo	Placebo comparator	Placebo vaccine Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: one year

Secondary outcomes (2)

To estimate utility scores for use in further health-economic models.
Scores will be computed from QoL questionnaires to measure this outcome.
Measured: one year
To evaluate health care resource utilization.
Health care visits, medications, hospitalizations and medical procedures will be collected to measure this outcome.
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Nov 2011

First posted10 Aug 2010 (estimated)
Study startJul 2010
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Smoking CessationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01178346
Sponsor's protocol ID: Nabi-4519
Status last verified: May 2012
First submitted: 5 Aug 2010
Last updated: 9 May 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
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Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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Impacto 2.0: Mobile Smoking Cessation Across Texas
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Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Health-Related Quality-of-Life and Health-Care Resource Utilization Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies
ClinicalTrials.gov ID: NCT01178346
Acronym / sponsor ID: Nabi-4519
Conditions: Smoking Cessation
Keywords: Pharmacoeconomic, Quality of Life, Health Outcomes, Smoking, NicVAX, Smoking vaccine, Smoking cessation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: Nabi BiopharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Jul 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 10 Aug 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
NicVAX	Experimental	Biological: NicVAX vaccineExperimental vaccine
Placebo	Placebo comparator	Biological: PlaceboPlacebo vaccine

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NicVAX vaccineNicVAX vaccine given 6 times over 6 months	Biological	NicVAX
PlaceboPlacebo vaccine given 6 times over 6 months	Biological	Placebo

Primary outcome

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.

2 secondary outcomes

To estimate utility scores for use in further health-economic models.
Time frame: one year
To evaluate health care resource utilization.
Time frame: one year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.

Related trials for Smoking Cessation

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
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RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Nabi Biopharmaceuticals

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NicVAX vaccine in people with Smoking Cessation, run by Nabi Biopharmaceuticals at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period. (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01178346.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2012.