University of Iowa News
June 13, 2006
UI Influenza Study Invites Participants Ages 18 To 64
Adults ages 18 to 64 in overall good health are invited to participate in an influenza vaccine study at University of Iowa Hospitals and Clinics. The study will test the effectiveness, safety and tolerability of different formulations of a study vaccine made by CSL Limited.
The study purpose is to help the Food and Drug Administration decide whether the influenza vaccine should be licensed and sold for use in the United States. The vaccine currently is used in Australia, Britain and other European countries.
Individuals who are allergic to eggs or have had severe reactions to an influenza vaccine are not eligible to participate.
The study involves three visits to UI Hospitals and Clinics within a three-week period. Participants will also be asked to record information at home after receiving study vaccine. The study will cover the cost of all required vaccine, tests and exams. Compensation will be available.
Participants will be placed in one of five different groups. Three groups will receive CSL vaccine with a preservative called Thimerosal, one group will receive CSL vaccine without Thimerosal and one group will receive a placebo (inactive substance).
Thimerosal has been commonly used in vaccines and other medical products in the United States and around the world. However, concerns about mercury in Thimerosal have prompted efforts to decrease the amount of Thimerosal used in vaccines. The CSL Limited vaccine with Thimerosal used in this study has only a small amount of the preservative routinely used for vaccines.
Patricia Winokur, M.D., UI associate professor of internal medicine, is the principal investigator for the UI portion of the trial.
The study is led by the National Institutes of Health and supported by CSL Limited, the maker of the vaccine. Up to 1,350 participants will be enrolled in the nationwide study, including 135 at the UI.
For more information, call 319-384-7245 or 319-384-9569 between 8 a.m. and 5 p.m. Monday through Friday.
University of Iowa Health Care describes the partnership between the UI Roy J. and Lucille A. Carver College of Medicine and UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide. Visit UI Health Care online at www.uihealthcare.com.
STORY SOURCE: University of Iowa Health Science Relations, 5137 Westlawn, Iowa City, Iowa 5224-1178
STUDY CONTACT: 319-384-7245 or 319-384-9569 between 8 a.m. and 5 p.m. Monday through Friday.
MEDIA CONTACT: Becky Soglin, 319 335-6660 firstname.lastname@example.org