PRAGUE, Czech Republic, October 9 /PRNewswire/ --
MedImmune today announced that six abstracts have been presented at the 2007 European Society for Paediatric Research (ESPR) Annual Meeting demonstrating the company's commitment to advancing the science of pediatric medicine. Data are from studies pertaining to MedImmune's approved and development-stage products, including both monoclonal antibodies and vaccines targeting two respiratory infectious diseases: influenza and respiratory syncytial virus (RSV).
"MedImmune is pleased to share data with the European medical community that may help improve the prevention and treatment of infectious diseases in children," said Frank Malinoski, M.D., Ph.D., senior vice president, medical and scientific affairs. "We are dedicated to advancing research of our commercialized products and our robust infectious disease pipeline to optimize children's health."
The ESPR meeting, which ran from October 6 to 8, 2007 in Prague, Czech Republic, featured the following poster and oral data presentations pertaining to MedImmune's infectious disease programs:
Influenza -- School-Based Influenza Vaccination of Elementary Students Reduced Countywide School Absenteeism (Poster Presentation) - J. Davis et al, Prague Congress Centre (Entrance #4), Poster Walk 10 BACKGROUND: This Maryland-based study investigated whether mass influenza vaccination in elementary schools with live-attenuated influenza vaccine (LAIV), or FluMist(R), was associated with a reduced rise in absenteeism in elementary, middle, and high schools during the influenza outbreak period. -- Postmarketing Evaluation of the Safety of Live-Attenuated Influenza Vaccine (FluMist) (Poster Presentation) - R. Baxter et al, Prague Congress Centre (Entrance #4), Poster Walk 10 BACKGROUND: LAIV was licensed in 2003 for use in healthy people aged five-49 years. As part of a commitment to the FDA, the safety of LAIV was evaluated post-licensure through this study. -- Prevention of the Influenza B Outbreak During the 2005-06 Influenza Season Through a Universal Vaccination Program in Children (Poster Presentation) - P. Piedra et al, Prague Congress Centre (Entrance #4), Poster Walk 10 BACKGROUND: A central Texas trial was conducted to determine vaccination coverage in children necessary to affect spread of influenza. -- Efficacy in Children of Live-Attenuated Influenza Vaccine (Oral Presentation) - J. Rhorer et al, Prague Congress Centre (Entrance #4), Session 10: Infection/Immunity BACKGROUND: Nine randomized clinical trials, including approximately 27,000 children aged six-72 months, evaluated the efficacy of LAIV against culture-confirmed influenza. The aim was to determine a precise estimate of vaccine efficacy to aid in evaluating LAIV in young children. RSV -- RSV Epidemiology in the U.S.: A Two-Year Summary from a Nationwide Surveillance Program (2004-2006) (Poster Presentation) - M. Boron et al, Prague Congress Centre (Entrance #4), Poster Walk 25 BACKGROUND: U.S. RSV surveillance data is available through the Centers for Disease Control and Prevention, state health departments and hospital laboratories; however, only regional data is reported. A nationwide active surveillance program was established to provide information on the epidemiology of RSV outbreaks in local areas, and results on local variants will be reported through this study. -- Phase 3 Trial of Motavizumab, an Enhanced Potency RSV Specific Monoclonal Antibody for the Prevention of Serious RSV Disease in High-Risk Infants (Oral Presentation) - E. Simoes et al, Monday, October 8, 2007 at 1:57 p.m. CEST, Prague Congress Centre (Entrance #4), Session 22: Randomized Controlled Trials BACKGROUND: RSV is the predominant cause of serious viral lower respiratory tract infection in young children. This study compared the safety and efficacy of palivizumab (Synagis(R)), an approved RSV-specific humanized monoclonal antibody, and motavizumab, an investigational RSV-specific monoclonal antibody, in preterm children at high-risk for serious RSV. Outside the United States, Abbott International, a global broad-based health care company, has the distribution rights to motavizumab.
Additional information regarding the European Society for Paediatric Research's Annual Meeting can be found at http://www.kenes.com/Paediatric-Research/.
Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease and is administered by intramuscular injection. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). Synagis has been used in more than one million children in the U.S. since its introduction in 1998. The first dose of Synagis should be administered prior to commencement of the RSV season. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the season.
Very rare cases (less than one per 100,000 patients) of anaphylaxis and rare (less than one per 1,000 patients) hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reaction occurs, caution should be used on re-administration of Synagis.
In clinical trials, the most common adverse events occurring at least one percent more frequently in Synagis-treated patients than controls were upper respiratory infection, otitis media, fever, and rhinitis. Cyanosis and arrhythmia were seen in children with CHD. Please see complete prescribing information at http://www.medimmune.com.
FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two-to-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life-threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.
Do not administer FluMist to children less than 24 months of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.
If Guillain-Barre syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.
Most common adverse reactions (occurring at greater than or equal to 10 percent in individuals receiving FluMist and at least five percent greater than in placebo) are runny nose or nasal congestion in recipients of all ages, fever greater than 100 degrees Fahrenheit in children two-to-six years of age, and sore throat in adults.
FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only. Please see complete prescribing information at http://www.medimmune.com.
MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website at http://www.medimmune.com.
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