Phase III clinical trial with Fluarix Tetra in influenza A and B published in The Lancet Child & Adolescent Health.- GlaxoSmithKline.

GlaxoSmithKline announced new data published in The Lancet Child & Adolescent Health from a Phase III clinical trial with Fluarix Tetra (inactivated quadrivalent influenza vaccine [IIV4]) which prevented influenza A and B in children six to 35 months of age. 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% (97.5% CI: 51.8�72.3) vaccine efficacy against laboratory-confirmed moderate-to-severe influenza, and 49.8% (97.5% CI: 41.8�56.8) 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% (97.5% CI: 64.3�86.6) and vaccine efficacy against influenza of any severity was 60.1% (97.5% CI: 49.1�69.0). The study also found that IIV4 reduced the impact of influenza on healthcare utilisation 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. The safety profile of the IIV4 was comparable with that of the non-influenza control vaccine. This is the first study to demonstrate the impact, in a randomised clinical trial, of influenza vaccination on the use of antibiotics.

See: "Prevention of vaccine-matched and mismatched influenza in children aged 6�35 months: a multinational randomised trial across five influenza seasons." Carine Claeys et al. The Lancet Child & Adolescent Health online first, 5 March 2018. DOI: https://doi.org/10.1016/S2352-4642(18)30062-2