Data presented to US CDC shows Fluarix Quadrivalent efficacy against influenza in young children.- GlaxoSmithKline.

GlaxoSmithKline presented at the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices meeting that Fluarix Quadrivalent (quadrivalent four-strain influenza vaccine) demonstrated 63.2% efficacy against moderate to severe influenza and 49.8% efficacy against influenza of any severity in children 6 months through 35 months of age. These results are based on a randomized, observer-blind, non-influenza vaccine-controlled trial that enrolled 12,018 children in five independent cohorts in 13 countries in Asia, Europe, and Central America from 2011 through the end of 2014.

The drug was immunogenic against all four vaccine strains (i.e., A/H1N1, A/H3N2, B/Victoria and B/Yamagata). The safety and reactogenicity profile was similar to vaccines used in the same age group. No safety signal was observed. Additionally, the study found that Fluarix Quadrivalent reduced healthcare utilization (i.e., antibiotic use, general practitioner visits and emergency department visits) related to confirmed influenza illness.

Comment: Fluarix Quadrivalent was first approved in 2012 in the U.S. for the prevention of influenza disease in people 3 years of age and older. In 2018, the indication was expanded to children 6 months and older. It is also approved in more than 30 other countries worldwide. Fluarix Quadrivalent is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluarix Quadrivalent is approved for use in persons aged 6 months and older.