title: Immunogenicity and reactogenicity associated with an 18-month booster dose of a new diphtheria-tetanus-whole cell pertussis vaccine.
abstract: OBJECTIVE
  To establish safety and immunogenicity of a reformulated whole cell pertussis based diphtheria-tetanus-pertussis vaccine (DTPw) at the 18-month booster stage following a 2, 4, and 6-month primary immunization course.
  
  
  METHODS
  Open trial in suburban Melbourne in 100 healthy children initially recruited through maternal and child health centres. Thirty-five subjects were bled prior to vaccination, and 4-6 weeks after vaccination. A 7-day diary card was used to record subject temperatures and other systemic and local clinical signs.
  
  
  RESULTS
  The increase in antibody geometric mean titres (GMT) after boosting was 19.5-fold (95%ci 14.2, 27.2) for tetanus and 26.5-fold (95%ci 16.6, 42.4) for diphtheria. Pertussis antibody GMTs also all showed substantial increases following the booster, with mean fold changes in titre ranging from 7.3 (Agg2) to 31.3 (Fha). Seventeen percent of subjects (95%ci 10%, 26%) experienced axillary temperatures > or = 38 degrees C during the 24-h period following vaccination. Low rates of significant (> 25 mm) injection site redness (13%) and swelling (8%) were recorded at 24 h postvaccination.
  
  
  CONCLUSIONS
  This vaccine was well tolerated by children at 18 months of age, and showed substantial boosting of antibody to all components.
authors.affiliation: Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia. nolan@cryptic.rch.unimelb.edu.au
authors.forename: T
authors.initials: T
authors.lastname: Nolan
authors.forename: G
authors.initials: G
authors.lastname: Hogg
authors.forename: M A
authors.initials: MA
authors.lastname: Darcy
authors.forename: J B
authors.initials: JB
authors.lastname: Carlin
authors.forename: M
authors.initials: M
authors.lastname: Skeljo
authors.forename: J
authors.initials: J
authors.lastname: Varigos
mesh_terms: D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects / Q000592:standards*; D007223:Infant; D008137:Longitudinal Studies
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine