title: Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects.
abstract: OBJECTIVE
  Adjuvanted influenza vaccines can overcome the poor antibody response of conventional non-adjuvanted vaccines in the elderly. We evaluated the immunogenicity, safety and clinical effectiveness of an MF59(®)-adjuvanted trivalent influenza vaccine (aTIV) compared with a non-adjuvanted vaccine (TIV) in subjects ≥65 years old, with or without co-morbidities.
  
  
  METHODS
  In 2010-2011, subjects (N=7082) were randomized to receive one dose of aTIV or TIV. Co-primary objectives were to assess lot-to-lot consistency of aTIV, non-inferiority, superiority and immunogenicity 22 days after vaccination. Clinical effectiveness, reactogenicity and serious adverse events were monitored up to Day 366.
  
  
  RESULTS
  The immunological equivalence of three lots of aTIV was demonstrated. aTIV was not only non-inferior to TIV but also elicited significantly higher antibody responses at Day 22 than TIV against all homologous and heterologous strains, even in subjects with co-morbidities. Superiority was not established. Reactogenicity was higher in the aTIV group, but reactions were mild to moderate and transient.
  
  
  CONCLUSIONS
  aTIV elicited a significantly higher antibody response than TIV, especially against A/H3N2 strains, although superiority by pre-defined criteria was not formally met. The study demonstrates potential immunological benefits of MF59-adjuvanted influenza vaccines for the elderly. This trial was registered with www.clinicaltrials.gov (NCT01162122).
authors.affiliation: Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.
authors.forename: Sharon E
authors.initials: SE
authors.lastname: Frey
authors.affiliation: Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.
authors.forename: Mari Rose Aplasca-De Los
authors.initials: MR
authors.lastname: Reyes
authors.affiliation: Centro de Atención e Investigación Médica (CAIMED), Bogotá, Colombia.
authors.forename: Humberto
authors.initials: H
authors.lastname: Reynales
authors.affiliation: Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA.
authors.forename: Nancy Nazaire
authors.initials: NN
authors.lastname: Bermal
authors.affiliation: Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA.
authors.forename: Uwe
authors.initials: U
authors.lastname: Nicolay
authors.affiliation: Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA.
authors.forename: Vas
authors.initials: V
authors.lastname: Narasimhan
authors.affiliation: Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Forleo-Neto
authors.affiliation: Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA. Electronic address: ashwani_kumar.arora@novartis.com.
authors.forename: Ashwani Kumar
authors.initials: AK
authors.lastname: Arora
mesh_terms: D000276:Adjuvants, Immunologic / Q000494:pharmacology*; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D000917:Antibody Formation; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D053122:Influenza A Virus, H3N2 Subtype; D007252:Influenza Vaccines / Q000276:immunology / Q000627:therapeutic use*; D007251:Influenza, Human / Q000517:prevention & control; D008297:Male; D011136:Polysorbates / Q000494:pharmacology*; D016037:Single-Blind Method; D013185:Squalene / Q000494:pharmacology*; D064166:Vaccine Potency
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene
keywords: Adjuvant; Elderly; Influenza vaccine; MF59; Non-inferiority; Superiority