title: Rapid licensure of a new, inactivated influenza vaccine in the United States.
abstract: BACKGROUND
  The unexpected problems at 1 of 2 US licensed manufacturers of trivalent inactivated influenza virus vaccine (TIV) in 2004 highlights the urgent need for additional vaccine sources. We evaluated a split virus TIV (Fluarix, GSK), to generate data supportive of a license application in the US.
  
  
  METHODS
  Healthy adults ages 18-64 years at four centers were randomly assigned to receive a single IM injection of Fluarix (n = 763) or placebo (n = 193) in double-blind fashion. Subjects were monitored for safety and serum hemagglutination-inhibition (HAI) titers determined before and 21 days after vaccination.
  
  
  RESULTS
  Vaccine was well tolerated, with only mild to moderate myalgias and injection site pain and redness being more common in vaccine than placebo recipients. Four-fold or greater increases in serum HAI titers were seen in 60%, 62% and 78% of vaccine recipients against the H1, H3, and B components of the vaccine, respectively, and post-vaccination titers of > 1:40 achieved in 98%, 99% and 99% of subjects, exceeding the prespecified criteria for acceptability for all three antigens.
  
  
  CONCLUSIONS
  Fluarix has a safety and immunogenicity profile like other US-licensed inactivated influenza vaccines and should be effective when used to immunize US adults. SUMMARY LINE: The results of this study were pivotal for the rapid approval of Fluarix in the US for use in adults 18 years of age or older.
authors.affiliation: University of Rochester, Rochester, New York 14642, USA. john_treanor@urmc.rochester.edu
authors.forename: John J
authors.initials: JJ
authors.lastname: Treanor
authors.forename: James D
authors.initials: JD
authors.lastname: Campbell
authors.forename: Rebecca C
authors.initials: RC
authors.lastname: Brady
authors.forename: Wendy A
authors.initials: WA
authors.lastname: Keitel
authors.forename: Mamadou
authors.initials: M
authors.lastname: Drame
authors.forename: Varsha K
authors.initials: VK
authors.lastname: Jain
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Innis
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006388:Hemagglutinins / Q000097:blood; D006801:Humans; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000592:standards; D007251:Influenza, Human / Q000517:prevention & control*; D008875:Middle Aged; D013997:Time Factors; D014481:United States
chemical_list: D006388:Hemagglutinins; D007252:Influenza Vaccines