Prospective Study Seeks to Assess RSV Burden in Outpatient Setting During
First Year of Life; Reinforcing Commitment to Pediatric Research
GAITHERSBURG, Md., June 29 /PRNewswire/ -- MedImmune continues to advance
its commitment to pediatric research with today's announcement of the first
observational prospective study designed to assess the burden of respiratory
syncytial virus (RSV) among preterm infants 32-to-35 weeks gestational age
(GA) in outpatient settings during their first year of life.
The study also seeks to gather virology data regarding the national onset
of the RSV season across the four geographic regions established by the U.S.
Centers for Disease Control & Prevention. Additionally, this two-year
observational study will look to identify the preterm infants that may be most
susceptible to serious RSV infection and the factors that may elevate that
"More than 98 percent of all children contract RSV before their second
birthday. Some of these children will be hospitalized and for many more, the
severity of the infection forces them to visit a healthcare provider or
hospital clinic on an outpatient basis," said Jessie Groothuis, M.D.,
MedImmune vice president, medical and scientific affairs, infectious disease.
"The intent of this first-of-its-kind prospective study is to add to the body
of evidence surrounding RSV burden of disease; gaining a snapshot of when the
RSV season starts and stops; as well as gathering insight into what risk
factors may make preterm infants most susceptible to RSV infection and to
serious RSV-related illness."
She went on to say that this information may help pediatricians, payers
and health policy makers make better decisions regarding the use of finite
healthcare resources on behalf of under-represented and under-served 32-to-35
weeks (GA) preterm infants.
This observational, prospective study will cover two consecutive RSV
seasons and begin patient enrollment in fall 2009, with a target of 3,000
participants across 100 outpatient sites in the United States. The study
population will include infants born 32-to-35 weeks (GA) who do not receive
RSV prophylaxis during their first RSV season.
Each year, up to 125,000 infants in the United States are hospitalized
with severe RSV infections, the leading cause of lower respiratory tract
infections in U.S. infants. RSV is the most common respiratory infection in
infancy or childhood. Approximately one-half of all infants are infected with
RSV during the first year of life, and nearly all children have been infected
at least once by the time they reach their second birthday. Children born
prematurely as well as those with chronic lung disease (CLD) or congenital
heart disease (CHD) are at highest risk for severe disease and hospitalization
due to RSV. The virus may also cause severe illness in other high-risk groups.
A recent study published in the New England Journal of Medicine found that
RSV accounts for one of every 13 visits to a pediatrician, one of every 38
emergency room trips, and inpatient hospital stays for one out of every 334
MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE:
AZN.L, NYSE: AZN), has approximately 3,100 employees worldwide and is
headquartered in Gaithersburg, Maryland. With an advancing pipeline of
promising candidates, we aim to be the next revolutionary force in
biotechnology by delivering life-changing products, industry-leading
performance, and a tireless commitment to improving patient health. For more
information, visit MedImmune's website at www.medimmune.com.
SOURCE: MedImmune 06/29/2009
CONTACT: Tor Constantino of MedImmune, +1-301-398-5801,
Web Site: http://www.medimmune.com