GREAT NEWS SHOULD BE POSTED TO THE THREAD:
avir
To print this story
Headlines Next Story
Aviron Announces Commencement of First Study
to Assess Widespread Pediatric Influenza
Vaccination
PR Newswire - August 06, 1998 11:20
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 aviron.com.
SOURCE Aviron
/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/
/Company News On-Call: prnewswire.com or fax, 800-758-5804,
ext. 114000/
/Web site: aviron.com
(AVIR)
Headlines Next Story
AVIR %MTC V%PRN P%PRN
|
