title: Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of ProQuad (measles, mumps, rubella, and varicella virus vaccine live).
abstract: OBJECTIVE
  A refrigerator-stable formulation of ProQuad has been developed to expand the utility of ProQuad to areas in which maintenance of a frozen cold chain (-15 degrees C or colder) during storage and transport may not be feasible. The objective of this study was to demonstrate that the immunogenicity and safety profiles of a refrigerator-stable formulation of ProQuad are similar to the recently licensed frozen formulation.
  
  
  METHODS
  In this double-blind, randomized, multicenter study, healthy 12- to 23-month-old children with negative vaccination and clinical histories for measles, mumps, rubella, varicella, and zoster were vaccinated with either the refrigerator-stable formulation of ProQuad (N = 1006) or the frozen formulation of ProQuad (N = 513). Patients were followed for 42 days after vaccination for adverse experiences. Immunogenicity was evaluated 6 weeks after vaccination.
  
  
  RESULTS
  The refrigerator-stable formulation of ProQuad was generally well tolerated. The incidence of adverse experiences was similar between groups. No vaccine-related serious adverse experiences were reported. For both groups, the response rate was > or = 97.7% for measles, mumps, and rubella, and the percentage of patients with a varicella zoster virus antibody titer of > or = 5 U/mL glycoprotein antigen-based enzyme-linked immunosorbent assay after vaccination was > or = 88.8%. The geometric mean titers for all antigens were numerically slightly higher in patients who received the refrigerator-stable formulation.
  
  
  CONCLUSIONS
  The refrigerator-stable formulation of ProQuad is generally well tolerated, highly immunogenic, and noninferior in terms of postvaccination antibody responses. This refrigerator-stable formulation may improve ease of vaccine administration, increase use of the vaccine throughout the world because of its improved storage conditions, and replace the frozen formulation of ProQuad or any dose of M-M-RII and Varivax in routine practice.
authors.affiliation: Dartmouth Medical School, Children's Hospital at Dartmouth, Lebanon, New Hampshire, USA. henry.bernstein@hitchcock.org
authors.forename: Henry H
authors.initials: HH
authors.lastname: Bernstein
authors.forename: Karen
authors.initials: K
authors.lastname: Eves
authors.forename: Kristy
authors.initials: K
authors.lastname: Campbell
authors.forename: Steven B
authors.initials: SB
authors.lastname: Black
authors.forename: Jerry D
authors.initials: JD
authors.lastname: Twiggs
authors.forename: Keith S
authors.initials: KS
authors.lastname: Reisinger
authors.forename: Ralph M
authors.initials: RM
authors.lastname: Conti
authors.forename: Carl-Erik
authors.initials: CE
authors.lastname: Flodmark
authors.forename: Lars
authors.initials: L
authors.lastname: Rombo
authors.forename: Stephanie
authors.initials: S
authors.lastname: Klopfer
authors.forename: Florian
authors.initials: F
authors.lastname: Schödel
authors.forename: Jonathan
authors.initials: J
authors.lastname: Hartzel
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Kuter
mesh_terms: D000914:Antibodies, Viral / Q000096:biosynthesis* / Q000097:blood; D019433:Chickenpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology* / Q000592:standards; D004311:Double-Blind Method; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods / Q000592:standards*; D005334:Fever / Q000139:chemically induced; D005615:Freezing; D006801:Humans; D007223:Infant; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology* / Q000592:standards; D012034:Refrigeration / Q000379:methods / Q000592:standards*; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000592:standards
chemical_list: D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D017778:Vaccines, Combined; C050102:measles, mumps, rubella, varicella vaccine