title: Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine coadministered with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine and/or meningococcal conjugate vaccine to healthy girls 11 to 18 years of age: results from a randomized open trial.
abstract: BACKGROUND
  A combined immunization strategy for administration of human papillomavirus (HPV) vaccine with other routine vaccines may lead to better compliance. Reactions and immunologic interference with concomitantly administered vaccines are unpredictable, necessitating clinical evaluation.
  
  
  METHODS
  This was a randomized, open study conducted at 48 centers in the United States (NCT00369824). Healthy girls 11 to 18 years of age were randomized equally to 1 of 6 groups to receive 3 doses of HPV-16/18 AS04-adjuvanted vaccine administered at 0, 1, and 6 or 1, 2, and 7 months, with or without 1 dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) and/or 1 dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MCV4) in different coadministration regimens (1283 girls vaccinated). Coadministered vaccines were injected at separate sites. Antibodies were measured for all vaccine components. Reactogenicity and safety were monitored.
  
  
  RESULTS
  The prespecified criteria for noninferiority were met for all primary and secondary immunogenicity end points, demonstrating similar immunogenicity of Tdap and MCV4 when given alone or coadministered with the HPV vaccine. Immunogenicity of the HPV vaccine (in terms of seroconversion rates and geometric mean antibody titers to HPV antigens) was similar, regardless of whether it was given alone or coadministered with Tdap and/or MCV4. No differences were observed in the reactogenicity profile of the HPV vaccine administered alone or coadministered with either Tdap and/or MCV4 in different regimens.
  
  
  CONCLUSIONS
  Concomitant administration of HPV-16/18 AS04-adjuvanted vaccine with Tdap and/or MCV4 in different regimens did not interfere with the immune response to any of the vaccines and had an acceptable safety profile.
authors.affiliation: Department of Pathology, University of New Mexico, Health Science Center, Albuquerque, NM 87131, USA. cwheeler@salud.unm.edu
authors.forename: Cosette M
authors.initials: CM
authors.lastname: Wheeler
authors.forename: Bryan M
authors.initials: BM
authors.lastname: Harvey
authors.forename: Michael E
authors.initials: ME
authors.lastname: Pichichero
authors.forename: Michael W
authors.initials: MW
authors.lastname: Simon
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Combs
authors.forename: Mark M
authors.initials: MM
authors.lastname: Blatter
authors.forename: Gary S
authors.initials: GS
authors.lastname: Marshall
authors.forename: Grégory
authors.initials: G
authors.lastname: Catteau
authors.forename: Kurt
authors.initials: K
authors.lastname: Dobbelaere
authors.forename: Dominique
authors.initials: D
authors.lastname: Descamps
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
authors.forename: Anne
authors.initials: A
authors.lastname: Schuind
mesh_terms: D000293:Adolescent; D000907:Antibodies, Bacterial / Q000276:immunology; D000914:Antibodies, Viral / Q000276:immunology; D000942:Antigens, Bacterial / Q000276:immunology; D000956:Antigens, Viral / Q000276:immunology; D002648:Child; D015331:Cohort Studies; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D005260:Female; D006801:Humans; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D000942:Antigens, Bacterial; D000956:Antigens, Viral; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D022401:Meningococcal Vaccines; D053918:Papillomavirus Vaccines; D018074:Vaccines, Conjugate