GlaxoSmithKline (GSK) has reported positive results from a trial that examined the safety and efficacy of Fluarix Quadrivalent vaccine for the treatment of influenza in children aged six months through 35 months.
The results have revealed that Fluarix Quadrivalent demonstrated 63.2% efficacy against moderate to severe influenza and 49.8% efficacy against influenza of any severity among the enrolled patients.
The randomised, observer-blind, non-influenza vaccine-controlled study enrolled 12,018 children.
The children were across five independent cohorts across 13 countries in Asia, Europe, and Central America from 2011 until the end of 2014.
The trial also found that that the safety and reactogenicity profile of Fluarix Quadrivalent is similar to other vaccines used in the same age group. It did not report any safety signal.
GSK Vaccines Scientific Affairs and Public Health vice-president Dr Leonard Friedland said: “Children six months through 35 months of age are particularly vulnerable to the flu, and the efficacy results from this trial are promising.
“Fluarix Quadrivalent can help ensure healthcare provider and parents have the ability to help protect young children against the flu.”
Furthermore, the efficacy trial revealed that Fluarix Quadrivalent reduced healthcare utilisation, including use of antibiotic, general practitioner visits, and emergency department visits related to confirmed influenza.
Seasonal influenza is an infectious respiratory condition, caused by flu viruses that spread between people and can cause a mild to severe illness.
Fluarix Quadrivalent is a vaccine designated for active immunisation for the prevention of disease caused by influenza viruses.
In 2012, the vaccine received an approval in the US for the prevention of influenza disease in patients aged three years and older.