title: Immunogenicity and safety of a combined measles, mumps, rubella and varicella live vaccine (ProQuad ®) administered concomitantly with a booster dose of a hexavalent vaccine in 12-23-month-old infants.
abstract: BACKGROUND
  Concomitant administration of vaccines can facilitate vaccination uptake, provided that no clinically significant effect on either vaccine is identified. We investigated the concomitant administration, during the second year of life, of one dose of the combined measles, mumps, rubella and varicella vaccine (ProQuad(®)) with a booster dose of a hexavalent vaccine.
  
  
  METHODS
  In this multicentre, open-label study, participants were randomized to 3 groups: Group 1, concomitant administration of one dose of ProQuad(®) and a booster of hexavalent vaccine; Group 2, one dose of ProQuad(®) alone; Group 3, a booster dose of hexavalent vaccine alone. Two serum samples were collected, within 7 days prior to vaccination and Days 42-56 post-vaccination for antibody testing.
  
  
  RESULTS
  Antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b following concomitant administration of ProQuad(®) and hexavalent vaccine were non-inferior compared with those following the individual vaccines. Antibody response rates to these antigens were all >95% in all groups. Antibody titres for the pertussis antigens following concomitant administration were also non-inferior to those following the individual vaccines. Antibody titres for the other valences were numerically comparable between groups with the exception of hepatitis B, Haemophilus influenzae type b, tetanus and poliomyelitis, which were higher in the concomitant than in the non-concomitant groups. The safety profiles of each vaccination regimen were comparable, with the exception of solicited ProQuad(®)-related injection-site reactions (Days 0-4), which occurred more frequently in the concomitant than in the non-concomitant groups.
  
  
  CONCLUSIONS
  These immunogenicity data support the concomitant administration of ProQuad(®) with a hexavalent vaccine. The safety profile of concomitant ProQuad(®) and hexavalent vaccination was also in line with that of the individual Summaries of Product Characteristics.
authors.affiliation: Pediatrics, Rathausgasse 1, 79336 Herbolzheim, Germany. Electronic address: klaus-deichmann@t-online.de.
authors.forename: Klaus A
authors.initials: KA
authors.lastname: Deichmann
authors.affiliation: ASP 7 Ragusa, Dipartimento di Prevenzione, servizio di Epidemiologia e Prevenzione, Via Aldo Licitra 11, 97100, Ragusa, Italy. Electronic address: servizio.epidemiologia@asp.rg.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ferrera
authors.affiliation: Sanofi Pasteur MSD, 162 Avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France.
authors.forename: Clément
authors.initials: C
authors.lastname: Tran
authors.affiliation: Sanofi Pasteur MSD, 162 Avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Thomas
authors.affiliation: Sanofi Pasteur MSD, 162 Avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: clinicaldevelopment@spmsd.com.
authors.forename: Cécile
authors.initials: C
authors.lastname: Eymin
authors.affiliation: Sanofi Pasteur MSD, 162 Avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Baudin
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood* / Q000276:immunology; D000914:Antibodies, Viral / Q000097:blood* / Q000276:immunology; D019433:Chickenpox Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D019741:Haemophilus influenzae type b / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary / Q000009:adverse effects; D007223:Infant; D008297:Male; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D014611:Vaccination; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D022542:Measles-Mumps-Rubella Vaccine; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; C541235:diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; C050102:measles, mumps, rubella, varicella vaccine
keywords: ClinicalTrials.gov NCT: 00432042; Hexavalent vaccine; Measles; Mumps; ProQuad(®) immunization; Rubella; Varicella