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Comparison of the s...
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Bernstein, Henry H.
(author)
Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of ProQuad (measles, mumps, rubella, and varicella virus vaccine live)
- Article/chapterEnglish2007
Publisher, publication year, extent ...
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2007-06-01
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American Academy of Pediatrics (AAP),2007
Numbers
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LIBRIS-ID:oai:lup.lub.lu.se:44b36105-5422-491f-9821-baf278f4a120
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https://lup.lub.lu.se/record/650670URI
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https://doi.org/10.1542/peds.2006-2283DOI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:115547647URI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:art swepub-publicationtype
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Subject category:ref swepub-contenttype
Notes
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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.
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Added entries (persons, corporate bodies, meetings, titles ...)
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Eves, Karen
(author)
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Campbell, Kristy
(author)
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Black, Steven B.
(author)
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Twiggs, Jerry D.
(author)
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Reisinger, Keith S.
(author)
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Conti, Ralph M.
(author)
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Flodmark, Carl-ErikLund University,Lunds universitet,Preventiv pediatrik,Forskargrupper vid Lunds universitet,Preventive Paediatrics,Lund University Research Groups(Swepub:lu)pedi-cfl
(author)
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Rombo, LarsKarolinska Institutet
(author)
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Klopfer, Stephanie
(author)
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Schodel, Florian
(author)
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Hartzel, Jonathan
(author)
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Kuter, Barbara J.
(author)
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Preventiv pediatrikForskargrupper vid Lunds universitet
(creator_code:org_t)
Related titles
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In:Pediatrics: American Academy of Pediatrics (AAP)119:6, s. 1299-13051098-42750031-4005
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Bernstein, Henry ...
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Eves, Karen
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Campbell, Kristy
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Black, Steven B.
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Twiggs, Jerry D.
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Reisinger, Keith ...
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Conti, Ralph M.
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Flodmark, Carl-E ...
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Rombo, Lars
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Klopfer, Stephan ...
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Schodel, Florian
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Hartzel, Jonatha ...
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Kuter, Barbara J ...
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Pediatrics
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Lund University
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Karolinska Institutet