Study of the Protective Effect of an Injectable Influenza Vaccine Against Influenza Illness in Adults Under 50 y.o.
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Influenza virus vaccine (Fluviral) Biological: Saline placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Educational/Counseling/Training |
| Official Title: | A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy of Fluviral™ Influenza Vaccine in Healthy Adults 18 to 49 Years of Age |
- Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.
- 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;
- 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.
| Estimated Enrollment: | 7400 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | May 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Good health by history and physical exam
- Reliable access to a telephone
- Study comprehension and informed consent
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:
- Severe reactions to other influenza vaccines
- Allergy to egg proteins
- Sensitivity to mercurials
Pregnancy/ high risk of pregnancy
- Positive urine pregnancy test before treatment
- Women of child-bearing potential without credible contraceptive plan
Contacts and Locations
Hide Study Locations| United States, California | |
| Benchmark Research | |
| Sacramento, California, United States, 95816 | |
| Benchmark Research | |
| San Fransisco, California, United States, 94102 | |
| United States, Colorado | |
| Radiant Research | |
| Denver, Colorado, United States, 80212 | |
| Longmont Med. Research Center | |
| Longmont, Colorado, United States, 80501 | |
| United States, Florida | |
| Miami Research Associates | |
| Miami, Florida, United States, 33173 | |
| University Clinical Research Associates | |
| Pembroke Pines, Florida, United States, 33024 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| Radiant Research | |
| Atlanta, Georgia, United States, 30342 | |
| Dwight D. Eisenhower Army Medical Center | |
| Ft. Gordon, Georgia, United States, 30905-5650 | |
| United States, Idaho | |
| Advanced Clinical Research | |
| Boise, Idaho, United States, 83704 | |
| Radiant Research | |
| Boise, Idaho, United States, 83704 | |
| United States, Illinois | |
| Radiant Research | |
| Chicago, Illinois, United States, 60610 | |
| United States, Iowa | |
| Preventive Intervention Center | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Kansas | |
| Johnson County ClinTrials | |
| Lenexa, Kansas, United States, 66219 | |
| United States, Kentucky | |
| Kentucky Pediatric/Adult Research | |
| Bardstown, Kentucky, United States, 40004 | |
| United States, Maryland | |
| Rockville Internal Medicine Group | |
| Rockville, Maryland, United States, 20854 | |
| United States, Nebraska | |
| Meridian Clinical Research | |
| Omaha, Nebraska, United States, 68134 | |
| United States, New Jersey | |
| Anderson and Collins Clinical Research | |
| Edison, New Jersey, United States, 08817 | |
| United States, New York | |
| Regional Clinical Research | |
| Endwell, New York, United States, 13760 | |
| United States, North Carolina | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| National Carolina Children and Adult Clinical Research Foundation | |
| Sylva, North Carolina, United States, 28779 | |
| Carolina medical Trials | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Radiant Research | |
| Cincinnati, Ohio, United States, 45236 | |
| United States, Pennsylvania | |
| Brandywine Clinical Research | |
| Downingtown, Pennsylvania, United States, 19355 | |
| United States, Rhode Island | |
| Omega Clinical Trials | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, South Carolina | |
| Radiant Research | |
| Anderson, South Carolina, United States, 29611 | |
| Spartanburg Medical Research | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| Clinical Research Associates | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Benchmark Research | |
| Austin, Texas, United States, 78705 | |
| Benchmark Research | |
| Austin, Texas, United States, 78728 | |
| Covance | |
| Austin, Texas, United States, 78752 | |
| Research Across America | |
| Dallas, Texas, United States, 75234 | |
| Allergy and Asthma Research Associates | |
| Dallas, Texas, United States, 75231 | |
| Benchmark Research | |
| Fort Worth, Texas, United States, 76135 | |
| Killeen Scott and White Regional Clinic | |
| Killeen, Texas, United States, 76543 | |
| Research Across America | |
| Plano, Texas, United States, 75093 | |
| Benchmark Research | |
| San Angelo, Texas, United States, 16904 | |
| United States, Utah | |
| J. Lewis Research, Inc. | |
| Salt Lake City, Utah, United States, 84109 | |
| J. Lewis Research, Inc. | |
| Salt Lake City, Utah, United States, 84121 | |
| J. Lewis Research | |
| West Jordan, Utah, United States, 84084 | |
| United States, Virginia | |
| PI-Coor Clinical Research, LLC | |
| Burke, Virginia, United States, 22015 | |
| Clinical Research Associates of Tidewater | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Center for Health Studies | |
| Seattle, Washington, United States, 98101 | |
| Study Director: | Nancy Bouveret, MD | ID Biomedical of Quebec |
More Information
No publications provided by ID Biomedical Corporation, Quebec
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00216242 History of Changes |
| Other Study ID Numbers: | IDB707-106 |
| Study First Received: | September 20, 2005 |
| Last Updated: | December 8, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ID Biomedical Corporation, Quebec:
|
influenza vaccine efficacy safety immunogenicity |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013