title: A Randomized, Double-Blind, Phase III Study of the Immunogenicity and Safety of a 9-Valent Human Papillomavirus L1 Virus-Like Particle Vaccine (V503) Versus Gardasil® in 9-15-Year-Old Girls.
abstract: BACKGROUND
  A 9-valent human papillomavirus (9vHPV) vaccine has been developed to prevent infections and diseases related to HPV 6/11/16/18 [as per the licensed quadrivalent HPV (qHPV) vaccine], as well as 5 additional oncogenic HPV types (HPV 31/33/45/52/58). Compared with the qHPV vaccine, the 9vHPV vaccine potentially increases the coverage of protection from 70% to 90% of cervical cancers. We compared the immunogenicity and safety of the 9vHPV vaccine versus the qHPV vaccine in 9-15-year-old girls.
  
  
  METHODS
  Participants (n = 600) were randomized to receive 9vHPV or qHPV vaccines on day 1, month 2 and month 6. Serology testing was performed on day 1 and month 7. HPV type-specific antibody titers (anti-HPV 6/11/16/18/31/33/45/52/58) were determined by competitive Luminex immunoassay and expressed as geometric mean titers and seroconversion rates. Vaccine safety was also assessed.
  
  
  RESULTS
  The HPV 6/11/16/18 immune responses elicited by the 9vHPV vaccine were comparable with those elicited by the qHPV vaccine. All participants (except 1 for HPV 45) receiving the 9vHPV vaccine seroconverted for HPV 31/33/45/52/58. The 9vHPV and qHPV vaccines showed comparable safety profiles, although the incidence of injection-site swelling was higher in the 9vHPV vaccine group.
  
  
  CONCLUSIONS
  In addition to immune responses to HPV 31/33/45/52/58, a 3-dose regimen of the 9vHPV vaccine elicited a similar immune response to HPV 6/11/16/18 when compared with the qHPV vaccine in girls aged 9-15 years. The safety profile was also similar for the 2 vaccines.
authors.affiliation: From the *Vaccine Research Centre, University of Tampere, Tampere, Finland; †Children's Hospital, Lund University, Lund, Sweden; ‡Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; §Vaccine Research Department, FISABIO-Public Health, Valencia, Spain; ¶Department of Health Sciences, University of Genoa, IRCSS AOU San Martino-IST, Genoa, Italy; ‖Department of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby, Denmark; **Sanofi Pasteur MSD, Lyon, France; and ††Merck & Co., Inc., Whitehouse Station, NJ.
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: Nicholas
authors.initials: N
authors.lastname: Brodszki
authors.forename: Pierre
authors.initials: P
authors.lastname: van Damme
authors.forename: Javier
authors.initials: J
authors.lastname: Diez-Domingo
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Icardi
authors.forename: Lone Kjeld
authors.initials: LK
authors.lastname: Petersen
authors.forename: Clément
authors.initials: C
authors.lastname: Tran
authors.forename: Stéphane
authors.initials: S
authors.lastname: Thomas
authors.forename: Alain
authors.initials: A
authors.lastname: Luxembourg
authors.forename: Martine
authors.initials: M
authors.lastname: Baudin
mesh_terms: D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood*; D002648:Child; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007118:Immunoassay; D030361:Papillomavirus Infections / Q000150:complications / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control*; D058425:Vaccines, Virus-Like Particle / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines; D058425:Vaccines, Virus-Like Particle