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Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of ProQuad (measles, mumps, rubella, and varicella virus vaccine live)

Bernstein, Henry H.; Eves, Karen; Campbell, Kristy; Black, Steven B.; Twiggs, Jerry D.; Reisinger, Keith S.; Conti, Ralph M.; Flodmark, Carl-Erik LU ; Rombo, Lars and Klopfer, Stephanie, et al. (2007) In Pediatrics 119(6). p.1299-1305
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... (More)
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 >= 97.7% for measles, mumps, and rubella, and the percentage of patients with a varicella zoster virus antibody titer of >= 5 U/mL glycoprotein antigen-based enzyme-linked immunosorbent assay after vaccination was >= 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. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
M-M-RII, Varivax, ProQuad, vaccine, varicella, rubella, measles, mumps, immunization
in
Pediatrics
volume
119
issue
6
pages
1299 - 1305
publisher
American Academy of Pediatrics
external identifiers
  • wos:000246948900073
  • scopus:34249911705
ISSN
1098-4275
DOI
10.1542/peds.2006-2283
language
English
LU publication?
yes
id
44b36105-5422-491f-9821-baf278f4a120 (old id 650670)
date added to LUP
2007-12-05 15:21:25
date last changed
2017-01-01 07:04:15
@article{44b36105-5422-491f-9821-baf278f4a120,
  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 >= 97.7% for measles, mumps, and rubella, and the percentage of patients with a varicella zoster virus antibody titer of >= 5 U/mL glycoprotein antigen-based enzyme-linked immunosorbent assay after vaccination was >= 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.},
  author       = {Bernstein, Henry H. and Eves, Karen and Campbell, Kristy and Black, Steven B. and Twiggs, Jerry D. and Reisinger, Keith S. and Conti, Ralph M. and Flodmark, Carl-Erik and Rombo, Lars and Klopfer, Stephanie and Schodel, Florian and Hartzel, Jonathan and Kuter, Barbara J.},
  issn         = {1098-4275},
  keyword      = {M-M-RII,Varivax,ProQuad,vaccine,varicella,rubella,measles,mumps,immunization},
  language     = {eng},
  number       = {6},
  pages        = {1299--1305},
  publisher    = {American Academy of Pediatrics},
  series       = {Pediatrics},
  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)},
  url          = {http://dx.doi.org/10.1542/peds.2006-2283},
  volume       = {119},
  year         = {2007},
}