title: Immunogenicity and tolerability of an MF59-adjuvanted, egg-derived, A/H1N1 pandemic influenza vaccine in children 6-35 months of age.
abstract: BACKGROUND
  Vaccines 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.
  
  
  METHODS
  Children 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.
  
  
  RESULTS
  All 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.
  
  
  CONCLUSIONS
  In 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.
authors: 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.
authors: Markus
authors: M
authors: Knuf
authors: Geert
authors: G
authors: Leroux-Roels
authors: Hans C
authors: HC
authors: Rümke
authors: Katia
authors: K
authors: Abarca
authors: Luis
authors: L
authors: Rivera
authors: Maria
authors: M
authors: Lattanzi
authors: Paola
authors: P
authors: Pedotti
authors: Ashwani
authors: A
authors: Arora
authors: Dorothee
authors: D
authors: Kieninger-Baum
authors: Giovanni
authors: G
authors: Della Cioppa
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002675:Child, Preschool; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D009500:Neutralization Tests; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects*; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects*; D014611:Vaccination / Q000379:methods
chemical_list: D000276:Adjuvants, Immunologic; D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene