title: Reactogenicity of tetanus, diphtheria, 5-component acellular pertussis vaccine administered as a sixth consecutive acellular pertussis vaccine dose to adolescents.
abstract: BACKGROUND
  Safety of a sixth consecutive dose of acellular pertussis vaccine in adolescents was assessed in a 2-armed, randomized study.
  
  
  METHODS
  Adolescents who had received 5 doses of acellular pertussis vaccine combined with diphtheria and tetanus toxoids (6-dose group) received 1 dose of reduced 5-component acellular pertussis vaccine combined with tetanus toxoid and reduced diphtheria toxoid (Tdap). Adolescents who had received a primary series of 3 doses of whole-cell pertussis and 1 acellular or whole-cell pertussis booster received 1 dose of Tdap vaccine (5-dose group).
  
  
  RESULTS
  Of 214 participants, 176 (82%) reported an injection-site reaction with pain (80%), erythema (22%), and swelling (19%) most frequently reported. A systemic reaction was reported by 169 of 214 (79%) with myalgia (66%), headache (42%), malaise (39%), and fever (9%) most frequently reported. The overall rate of solicited reactions was lower in the 6-dose group than in the 5-dose group (for injection-site reactions: 76.1% vs. 89.7%; for systemic reactions 72.6% vs. 86.6%). Significant differences were observed for injection-site pain, erythema, and for grade 1 or grade 2 increases in arm circumference. Fever, myalgia, and headache were reported at a significantly lower rate in the 6-dose group. Swelling >10 cm was observed in 5 patients (2%), 4 in the 5-dose group.
  
  
  CONCLUSIONS
  Tdap vaccine was safe when given to adolescents who had received 5 prior doses of acellular pertussis vaccine.
authors.affiliation: Pediatric Infectious Disease and Immunology, University Childrens Hospital, Universitätsklinikum Würzburg, Würzburg, Germany. liese_j@klinik.uni-wuerzburg.de
authors.forename: Johannes G
authors.initials: JG
authors.lastname: Liese
authors.forename: Nikolaus
authors.initials: N
authors.lastname: Rieber
authors.forename: Thomas
authors.initials: T
authors.lastname: Malzer
authors.forename: Marion
authors.initials: M
authors.lastname: Ocak
authors.forename: David R
authors.initials: DR
authors.lastname: Johnson
authors.forename: Michael D
authors.initials: MD
authors.lastname: Decker
mesh_terms: D000293:Adolescent; D002648:Child; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects*; D004487:Edema / Q000139:chemically induced; D004890:Erythema / Q000139:chemically induced; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005334:Fever / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects* / Q000379:methods*; D008297:Male; D010146:Pain / Q000139:chemically induced; D012871:Skin Diseases / Q000139:chemically induced / Q000473:pathology
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine