• Markus Knuf, Geert Leroux-Roels, Hans C Rümke, Katia Abarca, Luis Rivera, Maria Lattanzi, Paola Pedotti, Ashwani Arora, Dorothee Kieninger-Baum, and Giovanni Della Cioppa.
• From the *Zentrum für Kinder-und Jugendmedizin, Universitätsmedizin, Rheinland-Pfalz, Germany; †Center for Vaccinology, Ghent University and University Hospital, Ghent, Belgium; ‡Vaxinostics BV, University Vaccine Center Rotterdam Nijmegen, Rotterdam, The Netherlands; §Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile; ¶Hospital Maternidad Ntra Sra. de la Altagracia, Gazcue, Santo Domingo, The Dominican Republic; and ‖Novartis Vaccines and Diagnostics, Inc., Cambridge, Massachusetts.
• Pediatr. Infect. Dis. J. 2014 Dec 1; 33 (12): e320-9.

BackgroundVaccines against pandemic A/H1N1 influenza should provide protective immunity in children, because they are at greater risk of disease than adults. This study was conducted to identify the optimal dose of an MF59®-adjuvanted, egg-derived, A/H1N1 influenza vaccine for young children.MethodsChildren 6-11 months (N = 144) and 12-35 months (N = 186) of age received vaccine formulations containing either 3.75 μg antigen with half the standard dose of MF59 or 7.5 μg antigen with a standard dose of MF59, or a nonadjuvanted formulation containing 15 μg antigen (children 12-35 months only). Participants were given 2 primary vaccine doses 3 weeks apart, followed by 1 booster dose of MF59-adjuvanted seasonal influenza vaccine 1 year later. Immunogenicity was assessed by hemagglutination inhibition and microneutralization assays.ResultsAll vaccine formulations were highly immunogenic and met all 3 European licensure criteria after 2 doses. MF59-adjuvanted vaccines met all licensure criteria after 1 dose in both age cohorts, while nonadjuvanted vaccine did not meet all criteria after 1 dose in children 12-35 months. A single booster dose was highly immunogenic, and stable antibody persistence was observed in response to all vaccines. All vaccines were well tolerated.ConclusionsIn this study, a single dose of 3.75 μg antigen with half the standard dose of MF59 was shown to be optimal, providing adequate levels of immediate and long-term antibodies in pediatric subjects 6-35 months of age. These data demonstrated that MF59 adjuvant allowed for reduced antigen content and promoted significant long-term antibody persistence in children, with a satisfactory safety profile.

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