Study of the Protective Effect of an Injectable Influenza Vaccine Against Influenza Illness in Adults Under 50 y.o.

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00216242

Run by

ID Biomedical Corporation, Quebec

People needed

7400

Starts

2005-09-01

Expected to finish

2007-05-01

Last updated by the study team

2006-12-11

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Good health by history and physical exam
• Reliable access to a telephone
• Study comprehension and informed consent

You may not qualify if…

• 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

Where it is running

• Benchmark Research — Sacramento, California, United States
• Benchmark Research — San Francisco, California, United States
• Radiant Research — Denver, Colorado, United States
• Longmont Med. Research Center — Longmont, Colorado, United States
• Miami Research Associates — Miami, Florida, United States
• University Clinical Research Associates — Pembroke Pines, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Radiant Research — Atlanta, Georgia, United States
• Dwight D. Eisenhower Army Medical Center — Fort Eisenhower, Georgia, United States
• Advanced Clinical Research — Boise, Idaho, United States
• Radiant Research — Boise, Idaho, United States
• Radiant Research — Chicago, Illinois, United States
• Preventive Intervention Center — Iowa City, Iowa, United States
• Johnson County ClinTrials — Lenexa, Kansas, United States
• Kentucky Pediatric/Adult Research — Bardstown, Kentucky, United States
• Rockville Internal Medicine Group — Rockville, Maryland, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Anderson and Collins Clinical Research — Edison, New Jersey, United States
• Regional Clinical Research — Endwell, New York, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• National Carolina Children and Adult Clinical Research Foundation — Sylva, North Carolina, United States
• Carolina medical Trials — Winston-Salem, North Carolina, United States
• Radiant Research — Cincinnati, Ohio, United States
• Brandywine Clinical Research — Downingtown, Pennsylvania, United States
• Omega Clinical Trials — Warwick, Rhode Island, United States

Full record on ClinicalTrials.gov

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