title: Immunogenicity and Safety of a 9-Valent HPV Vaccine.
abstract: OBJECTIVE
  Prophylactic vaccination of youngwomen aged 16 to 26 years with the 9-valent (6/11/16/18/31/33/45/52/58) human papillomavirus (HPV) virus-like particle (9vHPV) vaccine prevents infection and disease. We conducted a noninferiority immunogenicity study to bridge the findings in young women to girls and boys aged 9 to 15 years.
  
  
  METHODS
  Subjects (N = 3066) received a 3-dose regimen of 9vHPV vaccine administered at day 1, month 2, and month 6. Anti-HPV serologic assays were performed at day 1 and month 7. Noninferiority required that the lower bound of 2-sided 95% confidence intervals of geometric mean titer ratios (boys:young women or girls:young women) be >0.67 for each HPV type. Systemic and injection-site adverse experiences (AEs) and serious AEs were monitored.
  
  
  RESULTS
  At 4 weeks after dose 3, >99% of girls, boys, and young women seroconverted for each vaccine HPV type. Increases in geometric mean titers to HPV types 6/11/16/18/31/33/45/52/58 were elicited in all vaccine groups. Responses in girls and boys were noninferior to those of young women. Persistence of anti-HPV responses was demonstrated through 2.5 years after dose 3. Administration of the 9vHPV vaccine was generally well tolerated. A lower proportion of girls (81.9%) and boys (72.8%) than young women (85.4%) reported injection-site AEs, most of which were mild to moderate in intensity.
  
  
  CONCLUSIONS
  These data support bridging the efficacy findings with 9vHPV vaccine in young women 16 to 26 years of age to girls and boys 9 to 15 years of age and implementing gender-neutral HPV vaccination programs in preadolescents and adolescents.
authors.affiliation: Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium; pierre.vandamme@uantwerp.be.
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Damme
authors.affiliation: Karolinska Institute at Danderyd Hospital, Uppsala, Sweden;
authors.forename: Sven Eric
authors.initials: SE
authors.lastname: Olsson
authors.affiliation: Kentucky Pediatric/Adult Research, Inc, Bardstown, Kentucky;
authors.forename: Stanley
authors.initials: S
authors.lastname: Block
authors.affiliation: Institut Català d'Oncologia, IDIBELL, CIBERESP, L'Hospitalet De Llobregat, Catalonia, Spain;
authors.forename: Xavier
authors.initials: X
authors.lastname: Castellsague
authors.affiliation: Department of Pediatrics, University of the Witwatersrand, Johannesburg, South Africa;
authors.forename: Glenda E
authors.initials: GE
authors.lastname: Gray
authors.affiliation: Instituto de Investigation Nutricional, Lima, Peru;
authors.forename: Teobaldo
authors.initials: T
authors.lastname: Herrera
authors.affiliation: Division of Infectious Diseases, Children's Hospital, National Taiwan University College of Medicine, Taipei, Taiwan;
authors.forename: Li-Min
authors.initials: LM
authors.lastname: Huang
authors.affiliation: Division of Infectious Disease and Immunology, Department of Pediatrics, Yonsei University College of Medicine, Severance Children's Hospital, Seoul, Korea;
authors.forename: Dong Soo
authors.initials: DS
authors.lastname: Kim
authors.affiliation: Faculty of Tropical Medicine, Mahidol University, Nakhon Pathom, Thailand; and.
authors.forename: Punnee
authors.initials: P
authors.lastname: Pitisuttithum
authors.affiliation: Merck and Company, Inc, Whitehouse Station, New Jersey.
authors.forename: Joshua
authors.initials: J
authors.lastname: Chen
authors.affiliation: Merck and Company, Inc, Whitehouse Station, New Jersey.
authors.forename: Susan
authors.initials: S
authors.lastname: Christiano
authors.affiliation: Merck and Company, Inc, Whitehouse Station, New Jersey.
authors.forename: Roger
authors.initials: R
authors.lastname: Maansson
authors.affiliation: Merck and Company, Inc, Whitehouse Station, New Jersey.
authors.forename: Erin
authors.initials: E
authors.lastname: Moeller
authors.affiliation: Merck and Company, Inc, Whitehouse Station, New Jersey.
authors.forename: Xiao
authors.initials: X
authors.lastname: Sun
authors.affiliation: Merck and Company, Inc, Whitehouse Station, New Jersey.
authors.forename: Scott
authors.initials: S
authors.lastname: Vuocolo
authors.affiliation: Merck and Company, Inc, Whitehouse Station, New Jersey.
authors.forename: Alain
authors.initials: A
authors.lastname: Luxembourg
mesh_terms: D000293:Adolescent; D000328:Adult; D052685:Alphapapillomavirus / Q000276:immunology*; D002648:Child; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D014943:Global Health; D006801:Humans; D008297:Male; D030361:Papillomavirus Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines / Q000008:administration & dosage*; D015995:Prevalence; D012189:Retrospective Studies; D014611:Vaccination / Q000379:methods*; D055815:Young Adult
chemical_list: D053918:Papillomavirus Vaccines