title: Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX®) and a tetanus monovalent vaccine in healthy adults: new considerations for the management of patients with tetanus-prone injuries.
abstract: In adults with a tetanus-prone injury, combined vaccines such as Tdap-IPV (REPEVAX®) can boost immunity against several diseases simultaneously. This Phase IIIb, parallel-group, open-label trial compared antibody responses to Tdap-IPV and tetanus monovalent vaccine (TMV; Vaccin Tétanique Pasteur® or Tetavax®) against tetanus toxoid 10 and 28 d post-vaccination. Between July and December 2009, four centers in France and five in Germany recruited healthy adults who had received a tetanus-containing vaccine 5-10 y previously. Participants were randomized 1:1 to receive at the first visit a single dose (0.5 mL) of Tdap-IPV or TMV, with follow-up visits at Day 10 and Day 28.
  
  
  RESULTS
  per protocol (PP) population immunogenicity at Day 10 (primary) and at Day 28 (secondary); safety throughout the study. Of 456 adults randomized, 223 received Tdap-IPV and 233 received TMV (PP population: 183 and 199 participants, respectively). All participants receiving Tdap-IPV and 99.0% receiving TMV had an anti-tetanus antibody concentration ≥ 0.1 IU/mL, confirming non-inferiority of Tdap-IPV to TMV (95% confidence interval of the difference: -1.2, 3.6). Number of adverse events reported was comparable in each group. Injection-site reactions were reported by 76.6% participants receiving Tdap-IPV and 74.6% receiving TMV. Systemic events (e.g., malaise, myalgia and headache) were reported in 47.7% and 39.7% of the Tdap-IPV and the TMV groups, respectively. Tdap-IPV is effective and well-tolerated for use in the management of tetanus-prone injuries in emergency settings in persons for whom a booster against diphtheria, pertussis and poliomyelitis is also needed.
authors.affiliation: CHU Clermont-Ferrand, INSERM/Centre d'Investigation Clinique (CIC) 501, UMR 1019 INRA-UdA, Univ-Clermont-1, Clermont-Ferrand, France.
authors.forename: Henri
authors.initials: H
authors.lastname: Laurichesse
authors.forename: Ulrich
authors.initials: U
authors.lastname: Zimmermann
authors.forename: Florence
authors.initials: F
authors.lastname: Galtier
authors.forename: Odile
authors.initials: O
authors.lastname: Launay
authors.forename: Xavier
authors.initials: X
authors.lastname: Duval
authors.forename: Patrick
authors.initials: P
authors.lastname: Richard
authors.forename: Christine
authors.initials: C
authors.lastname: Sadorge
authors.forename: Benoit
authors.initials: B
authors.lastname: Soubeyrand
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D005602:France; D005858:Germany; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D013742:Tetanus / Q000517:prevention & control*; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014947:Wounds and Injuries / Q000150:complications*
chemical_list: D000907:Antibodies, Bacterial; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; D017778:Vaccines, Combined