title: Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin.
abstract: BACKGROUND
  ProQuad, a vaccine containing antigens from M-M-RVAXPRO (measles, mumps and rubella vaccine) and VARIVAX (varicella vaccine), is indicated for simultaneous vaccination against measles, mumps, rubella and varicella (MMRV) in individuals from 12 months of age. To eliminate blood-derived products of human origin from the manufacturing process of the MMRV vaccine, recombinant human albumin was selected as a replacement for human serum albumin.
  
  
  METHODS
  This open-label, multicenter clinical trial (clinicaltrials.gov identifier NCT00560755) was designed to describe the safety profile of a 2-dose schedule of the MMRV vaccine at a 1-month interval in healthy children aged 12-22 months.
  
  
  RESULTS
  In total, 3388 children received at least 1 dose of the MMRV vaccine. Overall, 3376 (99.65%) children were included in the post-dose 1 safety analysis and 3342 (98.64%) in the post-dose 2 safety analysis. After doses 1 and 2, the frequencies of children experiencing solicited injection-site reactions (post-dose 1: erythema 14.31%; swelling 5.57% and pain 10.31%; post-dose 2: erythema 30.46%; swelling 13.23% and pain 11.49%), rashes of interest (post-dose 1: 11.4%; post-dose 2: 2.78%), vaccine-related nonserious systemic adverse events (post-dose 1: 34.86%; post-dose 2: 13.4%) and temperature ≥39.4 °C (post-dose 1: 25.24%; post-dose 2: 12.06%) were consistent with those observed in previous studies of the MMRV vaccine manufactured with human serum albumin. Neither serious allergic-type adverse events nor anaphylactic reactions were reported.
  
  
  CONCLUSIONS
  The results confirm the good safety profiles of MMRV and of measles, mumps and rubella vaccines manufactured with recombinant human albumin.
authors: Kinder-Jugendarztpraxis, Wildeshausen, Germany.
authors: Gabriela
authors: G
authors: Rüger
authors: Giovanni
authors: G
authors: Gabutti
authors: Hans
authors: H
authors: Rümke
authors: Lars
authors: L
authors: Rombo
authors: Enrique
authors: E
authors: Bernaola
authors: Javier
authors: J
authors: Diez-Domingo
authors: Federico
authors: F
authors: Martinon-Torres
authors: Birthe
authors: B
authors: Høgh
authors: Antreas
authors: A
authors: Konstantopoulos
authors: Anne
authors: A
authors: Fiquet
authors: Stéphane
authors: S
authors: Thomas
authors: Cécile
authors: C
authors: Eymin
authors: Martine
authors: M
authors: Baudin
mesh_terms: D000418:Albumins / Q000276:immunology*; D019433:Chickenpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011994:Recombinant Proteins; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000418:Albumins; D019433:Chickenpox Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D011994:Recombinant Proteins; D017778:Vaccines, Combined; C050102:measles, mumps, rubella, varicella vaccine