title: An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age.
abstract: BACKGROUND
  A 9-valent human papillomavirus (9vHPV) vaccine has recently been reported to be safe and highly efficacious against infection and disease related to HPV6/11/16/18/31/33/45/52/58. We evaluated the immunogenicity and safety of the 9vHPV vaccine administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine).
  
  
  METHODS
  This open-label, randomized, multicenter study enrolled 1054 males and females ages 11-15 years. Subjects were randomly assigned to each group in a 1:1 ratio. Subjects received a 0.5 mL dose of 9vHPV vaccine intramuscularly at day 1, months 2 and 6 and a 0.5 mL dose of REPEVAX either on day 1 (concomitant vaccination group; n = 526) or at month 1 (nonconcomitant vaccination group, n = 528). Serologic responses for each vaccine component were tested by 1-sided tests of noninferiority between groups. Systemic and injection-site adverse experiences (AEs) and serious AEs were monitored.
  
  
  RESULTS
  Noninferiority of anti-HPV geometric mean titers and seroconversion rates for all 9vHPV antigens were demonstrated for the concomitant group compared with the nonconcomitant group. Seroconversion rates for the 9vHPV vaccine types were ≥99.8% in both groups at month 7. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, all polio and pertussis antigens for both groups. There were no vaccine-related serious AEs.
  
  
  CONCLUSIONS
  Overall, concomitant administration of 9vHPV vaccine and REPEVAX was generally well tolerated and did not interfere with the immune response to either vaccine. This strategy would minimize the number of visits required to deliver each vaccine individually.
authors.affiliation: From the *Department of Pediatrics, Khon Kaen University, Khon Kaen, Thailand; †Coordinating Research Centre, Frederiksberg Hospital, Denmark; ‡Vaccine Research Center, University of Tampere, Tampere, Finland; §Paulinenstr. 71 a, Detmold, Germany; ¶Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; ‖Department of Gynecology and Obstetrics, Medical University of Vienna, Vienna, Austria; and Departments of **Clinical Research Vaccines and ††Biostatistics, Merck & Co., Inc., Kenilworth, NJ.
authors.forename: Pope
authors.initials: P
authors.lastname: Kosalaraksa
authors.forename: Jesper
authors.initials: J
authors.lastname: Mehlsen
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: Aino
authors.initials: A
authors.lastname: Forstén
authors.forename: Klaus
authors.initials: K
authors.lastname: Helm
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Damme
authors.forename: Elmar A
authors.initials: EA
authors.lastname: Joura
authors.forename: Karen
authors.initials: K
authors.lastname: Ciprero
authors.forename: Roger
authors.initials: R
authors.lastname: Maansson
authors.forename: Alain
authors.initials: A
authors.lastname: Luxembourg
authors.forename: Ajoke
authors.initials: A
authors.lastname: Sobanjo-ter Meulen
mesh_terms: D000293:Adolescent; D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D014611:Vaccination / Q000009:adverse effects / Q000379:methods; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; C051021:DTPP vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D053918:Papillomavirus Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined