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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NicVAX | Experimental | Experimental vaccine |
|
| Placebo | Placebo Comparator | Placebo vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NicVAX vaccine | Biological | NicVAX vaccine given 6 times over 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate utility scores for use in further health-economic models. | Scores will be computed from QoL questionnaires to measure this outcome. | one year |
| To evaluate health care resource utilization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Nabi Biopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NicVAX Investigator | Tucson | Arizona | 85724 | United States | ||
| NicVAX Investigator |
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| Placebo |
| Biological |
Placebo vaccine given 6 times over 6 months |
|
Health care visits, medications, hospitalizations and medical procedures will be collected to measure this outcome.
| one year |
| 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 |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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