GSK study proves efficacy of Fluarix Tetra flu shot in children
GSK today released new data published in The Lancet Child & Adolescent Health from a Phase III clinical trial using Fluarix Tetra (inactivated quadrivalent influenza vaccine) which prevented influenza A and B in children six to 35 months of age.
“Young children belong to one of the high-risk groups for influenza and are at particular risk of complications and severe disease, even when they are otherwise healthy. In addition, children play a major role in the dissemination of influenza in any community across the world," Thomas Breuer, chief medical officer, GSK Vaccines, said. “This study is the first randomized clinical trial designed to evaluate vaccine efficacy for a Quadrivalent influenza vaccine in young children. It adds to the growing body of evidence to support universal vaccination including all children from six months of age to help prevent influenza in this age group, as well as the spread of influenza across the community.”
Vaccine efficacy was highest against moderate-to-severe influenza, where the disease is associated with the greatest medical and socioeconomic burden. The study met its two primary endpoints, demonstrating 63.2% vaccine efficacy against laboratory-confirmed moderate-to-severe influenza, and 49.8% vaccine efficacy against influenza of any severity in children six to 35 months of age.
Data from the secondary endpoint, looking at culture-confirmed influenza due to influenza strains matching the vaccine strains, showed vaccine efficacy in this subset was even higher. Vaccine efficacy against moderate-to-severe influenza was 77.6% and vaccine efficacy against influenza of any severity was 60.1%.
The study also found that the vaccine reduced the impact of influenza on healthcare utilization and daily activities, approximately halving the likelihood of visits to a doctor, antibiotic use, parental work absence and missed day-care related to the current influenza illness. This is the first study to demonstrate the impact, in a randomized clinical trial, of influenza vaccination on the use of antibiotics.
“Young children belong to one of the high-risk groups for influenza and are at particular risk of complications and severe disease, even when they are otherwise healthy. In addition, children play a major role in the dissemination of influenza in any community across the world," Thomas Breuer, chief medical officer, GSK Vaccines, said. “This study is the first randomized clinical trial designed to evaluate vaccine efficacy for a Quadrivalent influenza vaccine in young children. It adds to the growing body of evidence to support universal vaccination including all children from six months of age to help prevent influenza in this age group, as well as the spread of influenza across the community.”
Vaccine efficacy was highest against moderate-to-severe influenza, where the disease is associated with the greatest medical and socioeconomic burden. The study met its two primary endpoints, demonstrating 63.2% vaccine efficacy against laboratory-confirmed moderate-to-severe influenza, and 49.8% vaccine efficacy against influenza of any severity in children six to 35 months of age.
Data from the secondary endpoint, looking at culture-confirmed influenza due to influenza strains matching the vaccine strains, showed vaccine efficacy in this subset was even higher. Vaccine efficacy against moderate-to-severe influenza was 77.6% and vaccine efficacy against influenza of any severity was 60.1%.
The study also found that the vaccine reduced the impact of influenza on healthcare utilization and daily activities, approximately halving the likelihood of visits to a doctor, antibiotic use, parental work absence and missed day-care related to the current influenza illness. This is the first study to demonstrate the impact, in a randomized clinical trial, of influenza vaccination on the use of antibiotics.