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The goal of this study is to determine whether the immune responses induced by Fluviral, the investigational vaccine, are comparable to those induced by Fluzone, which is an influenza vaccine currently licensed in the U.S. The study focuses on persons 50 years old and over. In addition, the study will compare the rate of reactions to the two vaccines, and the general health of persons who receive them over the 42 days after immunization.
Yearly influenza epidemics are responsible for excess hospitalizations and deaths in the elderly population, and also cause lost work and productivity among the healthy, working elderly. Fluviral, a product now licensed in Canada, is being tested to determine whether it is as active in causing immune responses, and as safe as a currently licensed U.S. vaccine in persons 50 y.o. and over.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza virus vaccine (Fluviral) | Biological | |||
| Influenza virus vaccine (Fluzone) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of signficant rises in serum antibody titers against viruses in the vaccines. | ||
| Geometric mean serum antibody titers on day 21. |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of specific, solicited vaccine reactogenicicty complaints. | ||
| Rates of adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Bouveret, MD | ID Biomedical of Quebec | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Research, Inc. | Pembroke Pines | Florida | 33024 | United States | ||
| Radiant Research |
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| Atlanta |
| Georgia |
| 30342 |
| United States |
| Radiant Research | Chicago | Illinois | 60610 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66211 | United States |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| Regional Clinical Research | Endwell | New York | 13760 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Radiant Research | Cincinnati | Ohio | 45236 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| PI-Coor Clinical Research | Fairfax | Virginia | 22030 | United States |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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