University of Iowa Children's Hospital is participating in a National Institutes of Health (NIH) clinical trial to test an investigational vaccine for 2009 H1N1 flu along with the seasonal influenza vaccine in children.
St. Louis University is the lead site for this pediatric study, which involves a total of six institutions and an expected 650 participants. UI Children's Hospital will enroll approximately 100 participants.
The study will examine safety and measure the body's immune response to the investigational H1N1 flu vaccine. In addition, the research will help determine how and when the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. It also will analyze potential problems of giving the vaccines together, such as whether one vaccine will undermine the protective power of the other.
"We need to know how the H1N1 flu and seasonal flu vaccines impact each other because both types of flu may be circulating this year," said Patricia Winokur, MD, principal investigator for the UI Children's Hospital site and a professor of internal medicine at the UI Carver College of Medicine.
Specifically, the investigational H1N1 influenza vaccine will be administered at the same time, before or after the seasonal influenza vaccine is given to different participants.
The Center for Disease Control and Prevention's Advisory Committee on Immunization Practices recently recommended all people ages 6 months to 24 years receive the H1N1 influenza vaccine when it is available. In making its recommendations, the group considered current disease patterns and current trends that showed populations most at risk of serious illness, among other factors.
The panel recommended vaccinating children ages 6 months to 18 because of the high number of cases of H1N1 influenza infection already seen in that age group. In addition, because children frequently are in school and day care, they are in close contact with each other, which makes it easier to spread disease.
The pediatric study is among several NIH-sponsored H1N1 studies that will collectively involve thousands of volunteers from all age groups nationwide. University of Iowa Health Care began participating in one of the adult H1N1 studies on August 11. |
