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

Henry H. Bernstein, Karen Eves, Kristy Campbell, Steven B. Black, Jerry D. Twiggs, Keith S. Reisinger, Ralph M. Conti, Carl Erik Flodmark, Lars Rombo, Stephanie Klopfer, Florian Schödel, Jonathan Hartzel, Barbara J. Kuter, Wilson P. Andrews, Jerry C. Bernstein, Joseph Bertino, Stanley L. Block, Louis Brine, Kevin Browngoehl, Matthew CoxRobert Dracker, Michael Gerber, Gregory C. Gray, J. Randy Hedgepeth, Harry Keyserling, Paul Lei, Michael Levin, Carl Lindgren, Stephen Luber, Edgardo Malacaman, Colin Marchant, Michelle Ogle, Shelly D. Senders, Julie Shepard, Douglas Short, Malcolm Sperling, Robert Stacks, James Troutman

Research output: Contribution to journalArticle

10 Citations (Scopus)

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°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.

Original languageEnglish (US)
Pages (from-to)e1299-e1305
JournalPediatrics
Volume119
Issue number6
DOIs
StatePublished - Jun 1 2007
Externally publishedYes

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Rubella virus
Safety
Vaccination
Mumps
Vaccines
Rubella
Measles
Chickenpox Vaccine
Antigens
Refrigeration
Human Herpesvirus 3
Chickenpox
measles, mumps, rubella, varicella vaccine
Herpes Zoster
Viral Load
Multicenter Studies
Antibody Formation
Glycoproteins
Enzyme-Linked Immunosorbent Assay
Maintenance

Keywords

  • Immunization
  • M-M-RII
  • Measles
  • Mumps
  • ProQuad
  • Rubella
  • Vaccine
  • Varicella
  • Varivax

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

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; Rombo, Lars; Klopfer, Stephanie; Schödel, Florian; Hartzel, Jonathan; Kuter, Barbara J.; Andrews, Wilson P.; Bernstein, Jerry C.; Bertino, Joseph; Block, Stanley L.; Brine, Louis; Browngoehl, Kevin; Cox, Matthew; Dracker, Robert; Gerber, Michael; Gray, Gregory C.; Hedgepeth, J. Randy; Keyserling, Harry; Lei, Paul; Levin, Michael; Lindgren, Carl; Luber, Stephen; Malacaman, Edgardo; Marchant, Colin; Ogle, Michelle; Senders, Shelly D.; Shepard, Julie; Short, Douglas; Sperling, Malcolm; Stacks, Robert; Troutman, James.

In: Pediatrics, Vol. 119, No. 6, 01.06.2007, p. e1299-e1305.

Research output: Contribution to journalArticle

Bernstein, HH, Eves, K, Campbell, K, Black, SB, Twiggs, JD, Reisinger, KS, Conti, RM, Flodmark, CE, Rombo, L, Klopfer, S, Schödel, F, Hartzel, J, Kuter, BJ, Andrews, WP, Bernstein, JC, Bertino, J, Block, SL, Brine, L, Browngoehl, K, Cox, M, Dracker, R, Gerber, M, Gray, GC, Hedgepeth, JR, Keyserling, H, Lei, P, Levin, M, Lindgren, C, Luber, S, Malacaman, E, Marchant, C, Ogle, M, Senders, SD, Shepard, J, Short, D, Sperling, M, Stacks, R & Troutman, J 2007, 'Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of proquad (measles, mumps, rubella, and varicella virus vaccine live)', Pediatrics, vol. 119, no. 6, pp. e1299-e1305. https://doi.org/10.1542/peds.2006-2283
Bernstein, Henry H. ; Eves, Karen ; Campbell, Kristy ; Black, Steven B. ; Twiggs, Jerry D. ; Reisinger, Keith S. ; Conti, Ralph M. ; Flodmark, Carl Erik ; Rombo, Lars ; Klopfer, Stephanie ; Schödel, Florian ; Hartzel, Jonathan ; Kuter, Barbara J. ; Andrews, Wilson P. ; Bernstein, Jerry C. ; Bertino, Joseph ; Block, Stanley L. ; Brine, Louis ; Browngoehl, Kevin ; Cox, Matthew ; Dracker, Robert ; Gerber, Michael ; Gray, Gregory C. ; Hedgepeth, J. Randy ; Keyserling, Harry ; Lei, Paul ; Levin, Michael ; Lindgren, Carl ; Luber, Stephen ; Malacaman, Edgardo ; Marchant, Colin ; Ogle, Michelle ; Senders, Shelly D. ; Shepard, Julie ; Short, Douglas ; Sperling, Malcolm ; Stacks, Robert ; Troutman, James. / Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of proquad (measles, mumps, rubella, and varicella virus vaccine live). In: Pediatrics. 2007 ; Vol. 119, No. 6. pp. e1299-e1305.
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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°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.",
keywords = "Immunization, M-M-RII, Measles, Mumps, ProQuad, Rubella, Vaccine, Varicella, Varivax",
author = "Bernstein, {Henry H.} and Karen Eves and Kristy Campbell and Black, {Steven B.} and Twiggs, {Jerry D.} and Reisinger, {Keith S.} and Conti, {Ralph M.} and Flodmark, {Carl Erik} and Lars Rombo and Stephanie Klopfer and Florian Sch{\"o}del and Jonathan Hartzel and Kuter, {Barbara J.} and Andrews, {Wilson P.} and Bernstein, {Jerry C.} and Joseph Bertino and Block, {Stanley L.} and Louis Brine and Kevin Browngoehl and Matthew Cox and Robert Dracker and Michael Gerber and Gray, {Gregory C.} and Hedgepeth, {J. Randy} and Harry Keyserling and Paul Lei and Michael Levin and Carl Lindgren and Stephen Luber and Edgardo Malacaman and Colin Marchant and Michelle Ogle and Senders, {Shelly D.} and Julie Shepard and Douglas Short and Malcolm Sperling and Robert Stacks and James Troutman",
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TY - JOUR

T1 - Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of proquad (measles, mumps, rubella, and varicella virus vaccine live)

AU - Bernstein, Henry H.

AU - Eves, Karen

AU - Campbell, Kristy

AU - Black, Steven B.

AU - Twiggs, Jerry D.

AU - Reisinger, Keith S.

AU - Conti, Ralph M.

AU - Flodmark, Carl Erik

AU - Rombo, Lars

AU - Klopfer, Stephanie

AU - Schödel, Florian

AU - Hartzel, Jonathan

AU - Kuter, Barbara J.

AU - Andrews, Wilson P.

AU - Bernstein, Jerry C.

AU - Bertino, Joseph

AU - Block, Stanley L.

AU - Brine, Louis

AU - Browngoehl, Kevin

AU - Cox, Matthew

AU - Dracker, Robert

AU - Gerber, Michael

AU - Gray, Gregory C.

AU - Hedgepeth, J. Randy

AU - Keyserling, Harry

AU - Lei, Paul

AU - Levin, Michael

AU - Lindgren, Carl

AU - Luber, Stephen

AU - Malacaman, Edgardo

AU - Marchant, Colin

AU - Ogle, Michelle

AU - Senders, Shelly D.

AU - Shepard, Julie

AU - Short, Douglas

AU - Sperling, Malcolm

AU - Stacks, Robert

AU - Troutman, James

PY - 2007/6/1

Y1 - 2007/6/1

N2 - 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°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.

AB - 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°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.

KW - Immunization

KW - M-M-RII

KW - Measles

KW - Mumps

KW - ProQuad

KW - Rubella

KW - Vaccine

KW - Varicella

KW - Varivax

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U2 - 10.1542/peds.2006-2283

DO - 10.1542/peds.2006-2283

M3 - Article

C2 - 17502347

AN - SCOPUS:34249911705

VL - 119

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SN - 0031-4005

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