MOUNTAIN VIEW, Calif., Aug. 6 /PRNewswire/ -- Aviron (Nasdaq: AVIR)
announced today the start of a large, multi-year clinical trial to assess the
impact of community-wide pediatric influenza immunization. The trial, to take
place in Temple, TX, is expected to involve about 15,000 vaccinated children
and is funded by a $3 million grant from the National Institute of Allergy and
Infectious Diseases of the National Institutes of Health (NIAID/NIH) and
awarded to Baylor College of Medicine. The trial will be conducted by the
Scott and White Hospital and Clinic in Temple, TX, Baylor College of Medicine
in Houston and the Texas Department of Health.
The non-randomized, open-label study will evaluate the impact of
vaccinating preschool and school-age children with FluMist(TM) intranasal
influenza vaccine based on the incidence of doctor visits for flu and
flu-related illnesses. The large number of trial participants will also
provide additional information on vaccine safety.
All healthy children in Temple between the ages of 18 months and 18 years
will be eligible to participate in the three-year trial. During each flu
season, which typically lasts from November to March, researchers will monitor
health-care visits in the Temple area using clinic and HMO databases. The
number of flu-related clinic visits will then be compared to a similar HMO
population in Texas, where FluMist(TM) will not be administered.
"This study represents an important step in understanding the impact on an
entire community when a key segment of the population is vaccinated against
influenza," stated J. Leighton Read, M.D., chairman and chief executive
officer of Aviron. "Since children play a key role in the spread of
influenza, we hope that high levels of vaccine coverage in children will have
benefits for kids as well as others in the population."
Epidemic influenza affects approximately 10-20 percent of the United
States population each year, resulting in 35-50 million cases of the illness
and approximately 20,000 deaths. By the age of 5, most children have had the
flu three or more times. FluMist(TM) has been tested in approximately
5500 individuals aged 12 months to 81 years, as part of a Collaborative
Research and Development Agreement (CRADA) between Aviron and the National
Institute of Allergy and Infectious Disease (NIAID) of the National Institutes
of Health (NIH). A pivotal Phase 3 clinical trial in children published in
the May 14 New England Journal of Medicine demonstrated a 93 percent
protection rate by FluMist(TM) against culture-confirmed influenza and a
98 percent reduction of influenza-associated otitis media (ear infections).
In another study among healthy adults, subjects receiving FluMist(TM)
experienced an 85 percent protection rate against laboratory-documented
influenza. Those receiving injectable vaccine experienced a 71 percent
protection rate. Aviron has an additional large, randomized, multi-center
double-blind, placebo-controlled study underway to evaluate the benefits of
FluMist(TM) in reducing work loss and health care utilization in adults.
"We are particularly pleased that this study is being led by a group at
Baylor College of Medicine with a long, established track record of research
in influenza vaccines. This study also shows the commitment of Scott and
White Hospital and Clinic and the Texas Department of Health investigators to
understand the deployment of preventative technologies for their population,"
Dr. Read said.
Aviron is a biopharmaceutical company based in Mountain View, CA focused
on prevention of disease. The company's goal is to develop vaccines which
offer cost-effective prevention of a wide range of infections that affect the
general population. The majority of Aviron's products under development are
live vaccines against viral infections. FluMist(TM) is currently under review
by the U.S. Food and Drug Administration. Products in clinical development
include parainfluenza (PIV-3) and, in collaboration with SmithKline Beecham
Biologicals, a subunit vaccine against Epstein-Barr Virus (EBV) infection, a
major cause of infectious mononucleosis. Products in pre-clinical development
include vaccines for respiratory syncytial virus (RSV), cytomegalovirus (CMV)
and genital herpes (HSV-2).
This press release contains forward-looking statements. Actual results
may differ materially from those suggested here. Additional information
concerning factors that could cause such a difference is contained in Aviron's
Annual Report on Form 10-K for the year ended December 31, 1997.
To receive an index and copies of recent press releases, call Aviron's
News-On-Call toll-free fax service, 800-758-5804, extension 114000.
Additional information about the company can be located at
http://www.aviron.com.
SOURCE Aviron
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CONTACT:
media, Karen Gilbert of Aviron, 650-919-6578;
or John Bluth or Louise Leavitt of Fleishman-Hillard,
212-453-2000, for Aviron; or investors, Lyn Christenson of
Aviron, 650-919-3716
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