Systems biology of immunity to MF59-adjuvanted versus non-adjuvanted trivalent seasonal influenza vaccines in early childhood. Homo sapiens

Here we applied systems approaches to investigate the innate and adaptive responses to trivalent inactivated influenza vaccine (TIV) and MF59-adjuvanted TIV (ATIV) in ninety 14-24 month old healthy children. Overall design: This study was a phase II, open labeled randomized control trial to describe immune & transcriptomic responses to trivalent inactivated vaccine (TIV, Imuvac®, Abbott Healthcare Products Ltd) and MF59-adjuvanted trivalent influenza vaccine (ATIV, Fluad®, Novartis Vaccines) in 14-26 month old, healthy children (n=90). Subjects within each vaccine arm were randomized to three cohorts: A, B and C. All subjects received two vaccinations at D0 and D28. Blood samples were obtained from all subjects at D0 (pre-vacciantion baseline) and D56. Additionally, blood samples were obtained at D29 (cohort A), D31 (Cohort B) and D35 (Cohort C) (D1, 3, and 7 post boost respectively). Staggered cohort design allowed to obtain 5 blood samples while liniting the number of blood draws for each subject to 3.