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The goal of this study is to determine whether Fluviral, an inactivated, injectable trivalent influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe enough to limit normal daily activities and that are shown by virus culture to be caused by influenza viruses. The study will also examine the safety of the vaccine and collect measurements of the immune system responses produced by the vaccine.
Yearly influenza (flu) epidemics cause a large burden of lost work and school time among younger persons and excess hospitalizations and deaths among the elderly. Injectable flu vaccines are generally believed to be effective, but formal studies using modern culture methods to prove this are limited. This study will compare the rate of respiratory illnesses associated with positive influenza virus cultures in healthy younger adults (a group at low risk for serious influenza complications) who have received Fluviral (an injectable flu vaccine) with the rate of such illnesses in healthy younger adults who have received an injection of saline (salt water). The rate of local vaccine reactions and other symptoms will be compared between the vaccine and salt water groups, and the immune responses to the vaccine measured.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza virus vaccine (Fluviral) | Biological | |||
| Saline placebo | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of culture and/or serologically-confirmed influenza-like illness during the interval from November to April following treatment; | ||
| Rate of solicited local and systemic common reactions in days 0 to 3 post-treatment; |
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Inclusion Criteria:
Exclusion Criteria:
Systolic BP >/= 140; diastolic BP >/= 90
Uncontrolled medical or psychiatric illness (change in last 3 months)
Cancer, or treatment for cancer within 3 years
Cardio-pulmonary disease requiring chronic treatment
Insulin dependent diabetes mellitus
Renal dysfunction (creatinine >/= 1.7 mg/dL)
Hemoglobinopathies
Clotting disorders that increase the risk of IM injections
Immunosuppressive illnesses or drugs
History of demyelinating disease (esp. Guillian-Barre syndrome)
Employment in professions at high risk for influenza transmission
Household contact with high-risk individuals
Receipt of:
a) Immunosuppressive drugs i) systemic glucocorticoids >/= 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 9 months before the study e) Other vaccines within 30 days before, or planned during, the study
History of:
Pregnancy/ high risk of pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Bouveret, MD | ID Biomedical of Quebec | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benchmark Research | Sacramento | California | 95816 | United States | ||
| Benchmark Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20236548 | Derived | Jackson LA, Gaglani MJ, Keyserling HL, Balser J, Bouveret N, Fries L, Treanor JJ. Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons. BMC Infect Dis. 2010 Mar 17;10:71. doi: 10.1186/1471-2334-10-71. |
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| Rate of other adverse events through approximately 135 days post-treatment; |
| Rate of four-fold rises in influenza specific antibody titers 21 days after treatment; |
| Rate of influenza-specific antibody titers equal to, or greater than, 40 at 21 days after treatment; |
| Geometric mean influenza-specific antibody titers at 21 days after treatment. |
| San Francisco |
| California |
| 94102 |
| United States |
| Radiant Research | Denver | Colorado | 80212 | United States |
| Longmont Med. Research Center | Longmont | Colorado | 80501 | United States |
| Miami Research Associates | Miami | Florida | 33173 | United States |
| University Clinical Research Associates | Pembroke Pines | Florida | 33024 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Radiant Research | Atlanta | Georgia | 30342 | United States |
| Dwight D. Eisenhower Army Medical Center | Fort Eisenhower | Georgia | 30905-5650 | United States |
| Advanced Clinical Research | Boise | Idaho | 83704 | United States |
| Radiant Research | Boise | Idaho | 83704 | United States |
| Radiant Research | Chicago | Illinois | 60610 | United States |
| Preventive Intervention Center | Iowa City | Iowa | 52242-1009 | United States |
| Johnson County ClinTrials | Lenexa | Kansas | 66219 | United States |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | United States |
| Rockville Internal Medicine Group | Rockville | Maryland | 20854 | United States |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | United States |
| Anderson and Collins Clinical Research | Edison | New Jersey | 08817 | United States |
| Regional Clinical Research | Endwell | New York | 13760 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| National Carolina Children and Adult Clinical Research Foundation | Sylva | North Carolina | 28779 | United States |
| Carolina medical Trials | Winston-Salem | North Carolina | 27103 | United States |
| Radiant Research | Cincinnati | Ohio | 45236 | United States |
| Brandywine Clinical Research | Downingtown | Pennsylvania | 19355 | United States |
| Omega Clinical Trials | Warwick | Rhode Island | 02886 | United States |
| Radiant Research | Anderson | South Carolina | 29611 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| Clinical Research Associates | Nashville | Tennessee | 37203 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Benchmark Research | Austin | Texas | 78728 | United States |
| Covance | Austin | Texas | 78752 | United States |
| Allergy and Asthma Research Associates | Dallas | Texas | 75231 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Benchmark Research | Fort Worth | Texas | 76135 | United States |
| Killeen Scott and White Regional Clinic | Killeen | Texas | 76543 | United States |
| Research Across America | Plano | Texas | 75093 | United States |
| Benchmark Research | San Angelo | Texas | 16904 | United States |
| J. Lewis Research, Inc. | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Inc. | Salt Lake City | Utah | 84121 | United States |
| J. Lewis Research | West Jordan | Utah | 84084 | United States |
| PI-Coor Clinical Research, LLC | Burke | Virginia | 22015 | United States |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | United States |
| Center for Health Studies | Seattle | Washington | 98101 | 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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