title: Safety of Tdap-IPV given one month after Td-IPV booster in healthy young adults: a placebo-controlled trial.
abstract: BACKGROUND
  In France, the only vaccines available for use as a pertussis booster in adults are combined vaccines containing adsorbed tetanus, diphtheria (adult formulation), acellular pertussis and inactivated poliovirus (Tdap-IPV). Adults may require a pertussis booster relatively soon after having received vaccines containing tetanus-diptheria antigens (Td) (occupational or familial circumstances such as new job, childbirth in recent past or future), although the safety of Tdap-IPV when administered soon after vaccination with Td is undocumented.
  
  
  METHODS
  In this randomized, double-blind, multi-centre study, we assessed the safety of Tdap-IPV administered one month after vaccination with tetanus, diphtheria (adult formulation), inactivated poliovirus vaccination (Td-IPV) in healthy adults vaccinated according to the French vaccination calendar (seven tetanus-diphtheria vaccinations by age 18 years). Subjects received either Td-IPV (n = 249) or placebo (n = 251) followed 1 month later by Tdap-IPV. Any adverse events (AEs) were recorded.
  
  
  RESULTS
  The safety of Tdap-IPV was similar when Tdap-IPV vaccine was administered one month after either Td-IPV or placebo: at seven days, 85.1% versus 93.4% subjects reported at least one reaction at the injection site, mainly pain (82.6% versus 92.1%); 40.5% versus 45.0%, at least one systemic AE (mainly headache: 26.4% versus 26.0%); fever concerned 1.7% of both groups. No serious vaccine-related AEs were reported. Both safety profiles corresponded to documented product characteristics.
  
  
  CONCLUSIONS
  Tdap-IPV may be administered to adults one month after Td-IPV without exacerbating post-vaccination side-effects.
authors.affiliation: Services des Maladies Infectieuses et Tropicales, Centre Hospitalier Universitaire Hôtel Dieu, Clermont-Ferrand, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Beytout
authors.forename: Odile
authors.initials: O
authors.lastname: Launay
authors.forename: Nicole
authors.initials: N
authors.lastname: Guiso
authors.forename: Anne
authors.initials: A
authors.lastname: Fiquet
authors.forename: Martine
authors.initials: M
authors.lastname: Baudin
authors.forename: Patrick
authors.initials: P
authors.lastname: Richard
authors.forename: Charles
authors.initials: C
authors.lastname: Baptiste
authors.forename: Benoît
authors.initials: B
authors.lastname: Soubeyrand
mesh_terms: D000293:Adolescent; D000328:Adult; D004168:Diphtheria Toxoid / Q000009:adverse effects*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects*; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005602:France; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods*; D008297:Male; D010146:Pain / Q000139:chemically induced; D010567:Pertussis Vaccine / Q000009:adverse effects*; D010919:Placebos / Q000008:administration & dosage; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects*; D012871:Skin Diseases / Q000139:chemically induced / Q000473:pathology; D013745:Tetanus Toxoid / Q000009:adverse effects*; D017778:Vaccines, Combined; D055815:Young Adult
chemical_list: C051021:DTPP vaccine; D004168:Diphtheria Toxoid; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D010567:Pertussis Vaccine; D010919:Placebos; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D017778:Vaccines, Combined