MedImmune announced today it will present results of a Phase 3 pediatric clinical study of its investigational quadrivalent live attenuated influenza vaccine (Q/LAIV) compared with its trivalent (LAIV) formulation. The abstract will be presented at the 49th Annual Meeting of Infectious Disease Society of America (IDSA) being held here October 20 through October 23, 2011.
The pivotal pediatric clinical study compared Q/LAIV to two trivalent formulations of MedImmune’s licensed seasonal influenza vaccine, FluMist® (Influenza Vaccine Live, Intranasal) and met its primary endpoint.
Currently licensed seasonal influenza vaccines are trivalent, containing three strains (two strains of type A influenza,A/H1N1 and A/H3N2, and one B lineage strain). However, as influenza B strains from 2 different lineages have circulated in recent years (B/Yamagata and B/Victoria), the quadrivalent vaccine contains four strains: A/H1N1, A/H3N2, and B strains from both of the B lineages. The quadrivalent vaccine is designed to offer protection against a broader range of B strains, and its development demonstrates MedImmune’s commitment to innovation within the infectious disease area.
Data from the pediatric Phase 3 study were included in the supplemental Biologics License Application (sBLA) for a quadrivalent (four-strain) version of FluMist® (Influenza Vaccine Live, Intranasal). The company submitted the sBLA early in the second quarter of this year.
This abstract will be available for viewing in the exhibit hall in the exhibit Hall B-1 from 12:15 until 2:15 on Friday, October 21, 2011 at the Boston Convention andExhibitionCenter.
Additional information about the 2011 IDSA conference can be found at http://www.idsa2011.org/
Important Safety and Eligibility Information for FluMist
What is FluMist®?
FluMist is the first and only nasal spray flu vaccine approved in the United Statesto help prevent influenza and is indicated for the active immunization of eligible individuals 2 to 49 years of age against influenza disease caused by influenza virus subtypes A and B contained in the vaccine.
Who may not be able to get FluMist?
You should not get FluMist if you: are allergic to eggs, gentamicin, gelatin, or arginine; have ever had a life-threatening reaction to influenza vaccinations; or are 2 through 17 years old and take aspirin or medicines containing aspirin–children or adolescents should not be given aspirin for 4 weeks after getting FluMist unless your healthcare provider tells you otherwise.
Children under 2 years old should not get FluMist because there is a chance they may wheeze (have difficulty with breathing) after getting FluMist.
Tell your healthcare provider if you: are currently wheezing; have a history of wheezing if under 5 years old; have had Guillain-Barré syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking Tamiflu®, Relenza®, amantadine, or rimantadine.
They will decide if FluMist is right for you.
What are the most common side effects of FluMist?
The most common side effects of FluMist are runny or stuffy nose; sore throat; and fever over 100 degrees F.
For more information, please visit www.FluMist.com.
MedImmune, the global biologics arm for AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune’s website at www.medimmune.com.