![]() anaphylaxis) to any component of the vaccine. Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reactions (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 6 months of age and older.ĭo not administer FLUAD QUADRIVALENT or AFLURIA QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. AFLURIA QUADRIVALENT is approved for use in persons 6 months of age and older.įLUCELVAX® QUADRIVALENT (Influenza Vaccine) is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. This indication is approved under accelerated approval based on the immune response elicited by FLUAD QUADRIVALENT.ĪFLURIA® QUADRIVALENT (Influenza Vaccine) is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUAD QUADRIVALENT is approved for use in persons 65 years of age and older. 1ĭEMONSTRATED EFFICACY OF FLUCELVAX (Influenza Vaccine) AGAINST CULTURE-CONFIRMED INFLUENZA IN THOSE 18 THROUGH 49 YEARS† 1įLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. ![]() The efficacy data of FLUCELVAX are relevant to FLUCELVAX QUADRIVALENT, as both vaccines are manufactured using the same process and have overlapping compositions. 1įLUCELVAX QUADRIVALENT (Influenza Vaccine) was proven noninferior to FLUCELVAX in adults 18 years and older (Study 3) based on data demonstrating on immunogenicity and seroconversion. Antigenically matched, culture-confirmed influenza 95% CI: 53.6-71.5 culture-confirmed influenza 95% CI: 51.3-68.5 RT-PCR or culture-confirmed influenza 95% CI: 45.7-62.1. FLUCELVAX QUADRIVALENT met the pre-defined success criterion defined as the lower limit of the 2-sided 95% CI of absolute vaccine efficacy greater than 20%. ![]() The full analysis set (FAS) for efficacy consisted of 4509 children and adolescents. Children and adolescents 9 through 17 years of age received a single dose of FLUCELVAX QUADRIVALENT or non-influenza comparator vaccine. Children in the 2-dose comparator group received non-influenza comparator as the first dose and saline placebo as the second dose. ![]() Children 2 through 8 years of age received either 1 or 2 doses (separated by 4 weeks) of FLUCELVAX QUADRIVALENT or comparator vaccine depending on the subject's prior influenza vaccination history. A total of 4513 children and adolescents 2 through 17 years received FLUCELVAX QUADRIVALENT (N=2258) or a non-influenza (meningococcal oligosaccharide diphtheria CRM197 conjugate) comparator vaccine (N=2255). *Absolute efficacy of FLUCELVAX QUADRIVALENT was evaluated in Study 2, a multinational, randomized, observer-blind, non-influenza vaccine comparator-controlled study during the following 3 influenza seasons: Southern Hemisphere 2017, Northern Hemisphere 2017-2018, and Northern Hemisphere 2018-2019. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |