title: Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study.
abstract: BACKGROUND
  Highly pathogenic avian influenza H5N1 viruses remain a threat to human health, with potential to become pandemic agents.
  
  
  METHODS
  This phase III, placebo-controlled, observer-blinded study evaluated the immunogenicity, cross-reactivity, safety, and lot consistency of 2 doses of oil-in-water (AS03(A)) adjuvanted H5N1 A/Indonesia/05/2005 (3.75 μg hemagglutinin antigen) prepandemic candidate vaccine in 4561 adults aged 18-91 years.
  
  
  RESULTS
  Humoral antibody responses in the H5N1 vaccine groups fulfilled US and European immunogenicity licensure criteria for pandemic vaccines in all age strata 21 days after the second dose. At 6 months after the administration of the primary dose, serum antibody seroconversion rates continued to fulfill licensure criteria. Neutralizing cross-clade immune responses were demonstrated against clade 1 A/Vietnam/1194/2004. Consistency was demonstrated for 3 consecutive H5N1 vaccine lots. Temporary injection-site pain was more frequent with H5N1 vaccine than placebo (89.3% and 70.7% in the 18-64 and ≥65 years strata vs 22.2% and 14.4% in the placebo groups). Unsolicited adverse event frequency, including medically attended and serious events, was similar between groups through day 364.
  
  
  CONCLUSIONS
  In adults and elderly adults, AS03(A)-adjuvanted H5N1 candidate vaccine was highly immunogenic for A/Indonesia/05/2005, with cross-reactivity against A/Vietnam/1194/2004. Temporary injection site reactions were more frequent with H5N1 vaccine than placebo, although the H5N1 vaccine was well tolerated overall. Clinical Trials Registration. NCT00616928.
authors: Canadian Center for Vaccinology, Departments of Pediatrics and Community Health and Epidemiology, IWK Health Centre and Dalhousie University, Halifax, Canada. joanne.langley@dal.ca
authors: Joanne M
authors: JM
authors: Langley
authors: George
authors: G
authors: Risi
authors: Michael
authors: M
authors: Caldwell
authors: Larry
authors: L
authors: Gilderman
authors: Bruce
authors: B
authors: Berwald
authors: Charles
authors: C
authors: Fogarty
authors: Terry
authors: T
authors: Poling
authors: Dennis
authors: D
authors: Riff
authors: Mira
authors: M
authors: Baron
authors: Louise
authors: L
authors: Frenette
authors: Eric
authors: E
authors: Sheldon
authors: Harry
authors: H
authors: Collins
authors: Marc
authors: M
authors: Shepard
authors: Marc
authors: M
authors: Dionne
authors: Daniel
authors: D
authors: Brune
authors: Linda
authors: L
authors: Ferguson
authors: David
authors: D
authors: Vaughn
authors: Ping
authors: P
authors: Li
authors: Louis
authors: L
authors: Fries
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