RE: Effective?10 Jan 2019 16:27
Cashmonies, hope this helps.....
A randomised, double-blind, placebo-controlled, single-centre trial part of the EU-funded European Universal Influenza Vaccines Secured Consortium ("UNISEC") project, to assess the immunogenicity, safety and exploratory efficacy of two different formulations and dosing regimens of FLU-v vaccine administered in healthy adults. In this trial, 176 subjects (aged 18-60 years) were assigned to either placebo or treatment arms.
The primary endpoint was to assess the immunogenicity responses of different formulations and regimens versus placebo at 42 and 180 days post vaccination in healthy volunteers
The primary endpoint of enhancing T-cell responses was met demonstrating a statistically significant enhancement of the number of responders positive for interferon gamma (IFNg) producing T-cells (p<0.001), at both 42 days and 180 days after single vaccination. IFNg is one of the most important markers of T-cell mediated immunity effective against influenza infection