Carine Claeys, Mamadou Drame, José García-Sicilia, Khalequ Zaman, Alfonso Carmona, Phu My Tran, Mariano Miranda, Federico Martinón-Torres, Franck Thollot, Michael Horn, Tino F Schwarz, Ulrich Behre, José M Merino, Iwona Sadowska-Krawczenko, Henryk Szymański, Peter Schu, Elisabeth Neumeier, Ping Li, Varsha K Jain, Bruce L Innis
BACKGROUND: GSK has modified the licensed monovalent bulk manufacturing process for its split-virion inactivated quadrivalent influenza vaccine (IIV4) to harmonize the process among different strains, resulting in an increased number of finished vaccine doses, while compensating for the change from inactivated trivalent influenza vaccine (IIV3) to IIV4. To confirm the manufacturing changes do not alter the profile of the vaccine, a clinical trial was conducted to compare IIV4 made by the currently licensed process with a vaccine made by the new (investigational) process (IIV4-I)...
April 18, 2018: BMC Infectious Diseases