title: Immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Tdap-IPV; Repevax) administered concomitantly versus non-concomitantly with an influenza vaccine (Vaxigrip) to adults aged ≥60 years: an open-label, randomised trial.
abstract: BACKGROUND
  Annual influenza vaccination provides an opportunity to administer a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Tdap-IPV) to the elderly. This study evaluated immune responses to and safety of the two vaccines administered concomitantly or sequentially to elderly individuals in France and Germany.
  
  
  METHODS
  Individuals aged ≥60 years who had received a diphtheria/tetanus booster within 5-15 years were randomised (1:1) to receive either Tdap-IPV and an inactivated influenza vaccine concomitantly (Group 1) or inactivated influenza vaccine then Tdap-IPV 28-35 days later (Group 2). Antibody titres were measured before and 28-35 days after each vaccination.
  
  
  RESULTS
  The mean age of randomised individuals (n=954) was 68.8 years. Post-vaccination seroprotection rates (≥0.1 IU/mL for diphtheria/tetanus and ≥8 1/dilution for polio) for Group 1 were non-inferior to Group 2 for diphtheria (85.4% vs. 87.5%), tetanus (both 100%), polio type 1 (99.8% vs. 100%), polio type 2 (both 100%) and polio type 3 (99.3% vs. 99.8%). Similarly, percentages of individuals with pertussis antibodies ≥5 EU/mL for Group 1 were non-inferior to Group 2: pertussis toxin (94.3% vs. 98.1%), filamentous haemagglutinin (99.8% vs. 100%), pertactin (97.3% vs. 96.0%), fimbriae 2 and 3 (91.7% vs. 89.5%). Post-vaccination geometric mean titres of anti-influenza haemagglutinin antibodies for Group 1 were non-inferior to Group 2. Adverse events following administration of Tdap-IPV were similar in both study groups, with no vaccine-related serious adverse events.
  
  
  CONCLUSIONS
  Tdap-IPV and inactivated influenza vaccine can be administered concomitantly in the elderly without impairing tolerability or the immune response to either vaccine.
authors: Internistische Gemeinschaftspraxis, Sülmerstraße 32, D74072, Heilbronn, Germany. Dr.UlrichZimmermann@web.de
authors: Ulrich
authors: U
authors: Zimmermann
authors: Gaëtan
authors: G
authors: Gavazzi
authors: Patrick
authors: P
authors: Richard
authors: Cécile
authors: C
authors: Eymin
authors: Benoît
authors: B
authors: Soubeyrand
authors: Martine
authors: M
authors: Baudin
mesh_terms: D000368:Aged; D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D015721:Diphtheria-Tetanus-Pertussis Vaccine / 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; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; C051021:DTPP vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D007252:Influenza Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; D015164:Vaccines, Inactivated; C478242:vaxigrip