Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad®)

Barbara J. Kuter; Michelle L Hoffman Brown; Jonathan Hartzel; Wendy R. Williams; Karen A. Eves; Steve Black; Henry Shinefield; Keith S. Reisinger; Colin D. Marchant; Bradley J. Sullivan; Marci Thear; Stephanie Klopfer; Jin Xu; Jacqueline O. Gress; Florian Schödel; Brian K. Allen; Justin C. Alvey; Edwin L. Anderson; Wilson P. Andrews; Basim Asmar; Parvin H. Azimi; Charles S. Ball; Stephen R. Barone; Henry Bernstein; Jerry C. Bernstein; Robert Bettis; Steven Black; Mark M. Blatter; Stan Block; Jeffrey L. Blumer; Frederick P. Boehm; Robert Brayden; Kenneth Bromberg; John L. Buttler; Archana Chatterjee; Ralph Conti; Daniel L. Coury; David E. Danhauer; Robert S. Daum; Penelope Dennehy; Marc Dionne; Buckley Eckert; Kathryn M. Edwards; Robert V. Ford; Stephen M. Fries; Mary C. Goessler; David P. Greenberg; Fernando A. Guerra; Juan Guerrero; Scott Halperin; Frederick W. Henderson; Richard Hornick; Louise K. Iwaishi; Candice E. Johnson; Ronald C. Jones; Robert Karasov; Barbara Law; Joseph Leader; Mark Lebel; Jay Leiberman; Martha Lepow; Stephen Luber; Colin Marchant; Gary S. Marshall; David O. Matson; H. Cody Meissner; Philip D. Milnes; William Moore; Sharon A. Nachman; Beth Nauert; Keith Perrin; Bernard Pollara; Mobeen H. Rathore; William C. Rees; Keith S. Reisinger; Margaret Rennels; Edward Rothstein; Raul Rudoy; Margaret Russell; Michael E. Ryan; Mark Sawyer; Shelly D. Senders; Steven A. Shapiro; Lawrence Sher; Henry Shinefield; Peter E. Silas; Malcolm J. Sperling; Tracy Stewart; Bradley Sullivan; James A. Taylor; Steven M. Thompson; James L. Troutman; Katherine F. Vaughn; Charmaine L. Venters; Emmanuel Walter; Barbara Watson; Alan Werzberger; J. Gary Wheeler; Karen R. Williams; Michael F. Yeiser; Ram Yogev

doi:10.4161/hv.2.5.3246

Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad®)

Barbara J. Kuter^*, Michelle L Hoffman Brown, Jonathan Hartzel, Wendy R. Williams, Karen A. Eves, Steve Black, Henry Shinefield, Keith S. Reisinger, Colin D. Marchant, Bradley J. Sullivan, Marci Thear, Stephanie Klopfer, Jin Xu, Jacqueline O. Gress, Florian Schödel, Brian K. Allen, Justin C. Alvey, Edwin L. Anderson, Wilson P. Andrews, Basim AsmarParvin H. Azimi, Charles S. Ball, Stephen R. Barone, Henry Bernstein, Jerry C. Bernstein, Robert Bettis, Steven Black, Mark M. Blatter, Stan Block, Jeffrey L. Blumer, Frederick P. Boehm, Robert Brayden, Kenneth Bromberg, John L. Buttler, Archana Chatterjee, Ralph Conti, Daniel L. Coury, David E. Danhauer, Robert S. Daum, Penelope Dennehy, Marc Dionne, Buckley Eckert, Kathryn M. Edwards, Robert V. Ford, Stephen M. Fries, Mary C. Goessler, David P. Greenberg, Fernando A. Guerra, Juan Guerrero, Scott Halperin, Frederick W. Henderson, Richard Hornick, Louise K. Iwaishi, Candice E. Johnson, Ronald C. Jones, Robert Karasov, Barbara Law, Joseph Leader, Mark Lebel, Jay Leiberman, Martha Lepow, Stephen Luber, Colin Marchant, Gary S. Marshall, David O. Matson, H. Cody Meissner, Philip D. Milnes, William Moore, Sharon A. Nachman, Beth Nauert, Keith Perrin, Bernard Pollara, Mobeen H. Rathore, William C. Rees, Keith S. Reisinger, Margaret Rennels, Edward Rothstein, Raul Rudoy, Margaret Russell, Michael E. Ryan, Mark Sawyer, Shelly D. Senders, Steven A. Shapiro, Lawrence Sher, Henry Shinefield, Peter E. Silas, Malcolm J. Sperling, Tracy Stewart, Bradley Sullivan, James A. Taylor, Steven M. Thompson, James L. Troutman, Katherine F. Vaughn, Charmaine L. Venters, Emmanuel Walter, Barbara Watson, Alan Werzberger, J. Gary Wheeler, Karen R. Williams, Michael F. Yeiser, Ram Yogev

^*Corresponding author for this work

Pediatrics

Research output: Contribution to journal › Article › peer-review

49 Scopus citations

Abstract

Background: A combination measles, mumps, rubella, and varicella vaccine (ProQuad®, Merck & Co., Inc, West Point, PA) was evaluated in five clinical trials. Use of ProQuad® would result in fewer injections for children and would facilitate universal immunization against all four diseases. Objective: To describe the combined results obtained from the studies conducted dur-ing the clinical development program for ProQuad®. Methods: A total of 5833 healthy children, 12-23 months of age, and 399 healthy children, 4-6 years of age, received 1 or 2 doses of ProQuad® in five controlled clinical trials. M-M-R®II and VARIVAX® were used as the control for most studies. Safety was evaluated for six weeks postvaccination and immunogenicity was assessed six weeks after each dose by a sensitive assay (ELISA or gpELISA). Results: A single dose of ProQuad® in 12- to 23-month-old children was shown to be as immunogenic as a single dose of M-M-R®II and VARIVAX® and was generally well tolerated. ProQuad® can be used concomitantly with other vaccines (hepatitis B and Haemophilus influenzae b). A higher rate of fever was reported after 1 dose of ProQuad® compared to M-M-R®II and VARIVAX®, but fever episodes were transient without long-term sequelae. Both a 2-dose regimen of ProQuad® in 12- to 23-month-olds and use of ProQuad® in place of M-M-R®II at 4-6 years were shown to be immunogenic and well tolerated. The incidence of adverse experiences following a second dose of ProQuad® was lower than that following the initial dose. Conclusions: A single dose of ProQuad® is as immunogenic as M-M-R®II and VARIVAX® and is well tolerated in a 1- or 2-dose schedule. ProQuad® should easily fit into the routine immunization schedule.

Original language	English (US)
Pages (from-to)	205-214
Number of pages	10
Journal	Human vaccines
Volume	2
Issue number	5
DOIs	https://doi.org/10.4161/hv.2.5.3246
State	Published - 2006

Funding

Drs. Black, Shinefield, and Reisinger are speakers for Merck & Co., Inc. and receive research funding from Merck & Co., Inc. Doctors Marchant and Sullivan as well as the Study Group for ProQuad® participated in these research studies that were sponsored by Merck & Co., Inc.

Keywords

Combination vaccines
Measles
Mumps
Rubella
Varicella

ASJC Scopus subject areas

Pharmacology, Toxicology and Pharmaceutics(all)
Immunology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.4161/hv.2.5.3246

Cite this

Kuter, B. J., Brown, M. L. H., Hartzel, J., Williams, W. R., Eves, K. A., Black, S., Shinefield, H., Reisinger, K. S., Marchant, C. D., Sullivan, B. J., Thear, M., Klopfer, S., Xu, J., Gress, J. O., Schödel, F., Allen, B. K., Alvey, J. C., Anderson, E. L., Andrews, W. P., ... Yogev, R. (2006). Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad®). Human vaccines, 2(5), 205-214. https://doi.org/10.4161/hv.2.5.3246

@article{918153a1d70c465da662efe0b455b8a6,

title = "Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad{\textregistered})",

abstract = "Background: A combination measles, mumps, rubella, and varicella vaccine (ProQuad{\textregistered}, Merck & Co., Inc, West Point, PA) was evaluated in five clinical trials. Use of ProQuad{\textregistered} would result in fewer injections for children and would facilitate universal immunization against all four diseases. Objective: To describe the combined results obtained from the studies conducted dur-ing the clinical development program for ProQuad{\textregistered}. Methods: A total of 5833 healthy children, 12-23 months of age, and 399 healthy children, 4-6 years of age, received 1 or 2 doses of ProQuad{\textregistered} in five controlled clinical trials. M-M-R{\textregistered}II and VARIVAX{\textregistered} were used as the control for most studies. Safety was evaluated for six weeks postvaccination and immunogenicity was assessed six weeks after each dose by a sensitive assay (ELISA or gpELISA). Results: A single dose of ProQuad{\textregistered} in 12- to 23-month-old children was shown to be as immunogenic as a single dose of M-M-R{\textregistered}II and VARIVAX{\textregistered} and was generally well tolerated. ProQuad{\textregistered} can be used concomitantly with other vaccines (hepatitis B and Haemophilus influenzae b). A higher rate of fever was reported after 1 dose of ProQuad{\textregistered} compared to M-M-R{\textregistered}II and VARIVAX{\textregistered}, but fever episodes were transient without long-term sequelae. Both a 2-dose regimen of ProQuad{\textregistered} in 12- to 23-month-olds and use of ProQuad{\textregistered} in place of M-M-R{\textregistered}II at 4-6 years were shown to be immunogenic and well tolerated. The incidence of adverse experiences following a second dose of ProQuad{\textregistered} was lower than that following the initial dose. Conclusions: A single dose of ProQuad{\textregistered} is as immunogenic as M-M-R{\textregistered}II and VARIVAX{\textregistered} and is well tolerated in a 1- or 2-dose schedule. ProQuad{\textregistered} should easily fit into the routine immunization schedule.",

keywords = "Combination vaccines, Measles, Mumps, Rubella, Varicella",

author = "Kuter, {Barbara J.} and Brown, {Michelle L Hoffman} and Jonathan Hartzel and Williams, {Wendy R.} and Eves, {Karen A.} and Steve Black and Henry Shinefield and Reisinger, {Keith S.} and Marchant, {Colin D.} and Sullivan, {Bradley J.} and Marci Thear and Stephanie Klopfer and Jin Xu and Gress, {Jacqueline O.} and Florian Sch{\"o}del and Allen, {Brian K.} and Alvey, {Justin C.} and Anderson, {Edwin L.} and Andrews, {Wilson P.} and Basim Asmar and Azimi, {Parvin H.} and Ball, {Charles S.} and Barone, {Stephen R.} and Henry Bernstein and Bernstein, {Jerry C.} and Robert Bettis and Steven Black and Blatter, {Mark M.} and Stan Block and Blumer, {Jeffrey L.} and Boehm, {Frederick P.} and Robert Brayden and Kenneth Bromberg and Buttler, {John L.} and Archana Chatterjee and Ralph Conti and Coury, {Daniel L.} and Danhauer, {David E.} and Daum, {Robert S.} and Penelope Dennehy and Marc Dionne and Buckley Eckert and Edwards, {Kathryn M.} and Ford, {Robert V.} and Fries, {Stephen M.} and Goessler, {Mary C.} and Greenberg, {David P.} and Guerra, {Fernando A.} and Juan Guerrero and Scott Halperin and Henderson, {Frederick W.} and Richard Hornick and Iwaishi, {Louise K.} and Johnson, {Candice E.} and Jones, {Ronald C.} and Robert Karasov and Barbara Law and Joseph Leader and Mark Lebel and Jay Leiberman and Martha Lepow and Stephen Luber and Colin Marchant and Marshall, {Gary S.} and Matson, {David O.} and Meissner, {H. Cody} and Milnes, {Philip D.} and William Moore and Nachman, {Sharon A.} and Beth Nauert and Keith Perrin and Bernard Pollara and Rathore, {Mobeen H.} and Rees, {William C.} and Reisinger, {Keith S.} and Margaret Rennels and Edward Rothstein and Raul Rudoy and Margaret Russell and Ryan, {Michael E.} and Mark Sawyer and Senders, {Shelly D.} and Shapiro, {Steven A.} and Lawrence Sher and Henry Shinefield and Silas, {Peter E.} and Sperling, {Malcolm J.} and Tracy Stewart and Bradley Sullivan and Taylor, {James A.} and Thompson, {Steven M.} and Troutman, {James L.} and Vaughn, {Katherine F.} and Venters, {Charmaine L.} and Emmanuel Walter and Barbara Watson and Alan Werzberger and Wheeler, {J. Gary} and Williams, {Karen R.} and Yeiser, {Michael F.} and Ram Yogev",

note = "Funding Information: Drs. Black, Shinefield, and Reisinger are speakers for Merck & Co., Inc. and receive research funding from Merck & Co., Inc. Doctors Marchant and Sullivan as well as the Study Group for ProQuad{\textregistered} participated in these research studies that were sponsored by Merck & Co., Inc.",

year = "2006",

doi = "10.4161/hv.2.5.3246",

language = "English (US)",

volume = "2",

pages = "205--214",

journal = "Human vaccines",

issn = "1554-8600",

publisher = "Landes Bioscience",

number = "5",

}

Kuter, BJ, Brown, MLH, Hartzel, J, Williams, WR, Eves, KA, Black, S, Shinefield, H, Reisinger, KS, Marchant, CD, Sullivan, BJ, Thear, M, Klopfer, S, Xu, J, Gress, JO, Schödel, F, Allen, BK, Alvey, JC, Anderson, EL, Andrews, WP, Asmar, B, Azimi, PH, Ball, CS, Barone, SR, Bernstein, H, Bernstein, JC, Bettis, R, Black, S, Blatter, MM, Block, S, Blumer, JL, Boehm, FP, Brayden, R, Bromberg, K, Buttler, JL, Chatterjee, A, Conti, R, Coury, DL, Danhauer, DE, Daum, RS, Dennehy, P, Dionne, M, Eckert, B, Edwards, KM, Ford, RV, Fries, SM, Goessler, MC, Greenberg, DP, Guerra, FA, Guerrero, J, Halperin, S, Henderson, FW, Hornick, R, Iwaishi, LK, Johnson, CE, Jones, RC, Karasov, R, Law, B, Leader, J, Lebel, M, Leiberman, J, Lepow, M, Luber, S, Marchant, C, Marshall, GS, Matson, DO, Meissner, HC, Milnes, PD, Moore, W, Nachman, SA, Nauert, B, Perrin, K, Pollara, B, Rathore, MH, Rees, WC, Reisinger, KS, Rennels, M, Rothstein, E, Rudoy, R, Russell, M, Ryan, ME, Sawyer, M, Senders, SD, Shapiro, SA, Sher, L, Shinefield, H, Silas, PE, Sperling, MJ, Stewart, T, Sullivan, B, Taylor, JA, Thompson, SM, Troutman, JL, Vaughn, KF, Venters, CL, Walter, E, Watson, B, Werzberger, A, Wheeler, JG, Williams, KR, Yeiser, MF & Yogev, R 2006, 'Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad®)', Human vaccines, vol. 2, no. 5, pp. 205-214. https://doi.org/10.4161/hv.2.5.3246

TY - JOUR

T1 - Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad®)

AU - Kuter, Barbara J.

AU - Brown, Michelle L Hoffman

AU - Hartzel, Jonathan

AU - Williams, Wendy R.

AU - Eves, Karen A.

AU - Black, Steve

AU - Shinefield, Henry

AU - Reisinger, Keith S.

AU - Marchant, Colin D.

AU - Sullivan, Bradley J.

AU - Thear, Marci

AU - Klopfer, Stephanie

AU - Xu, Jin

AU - Gress, Jacqueline O.

AU - Schödel, Florian

AU - Allen, Brian K.

AU - Alvey, Justin C.

AU - Anderson, Edwin L.

AU - Andrews, Wilson P.

AU - Asmar, Basim

AU - Azimi, Parvin H.

AU - Ball, Charles S.

AU - Barone, Stephen R.

AU - Bernstein, Henry

AU - Bernstein, Jerry C.

AU - Bettis, Robert

AU - Black, Steven

AU - Blatter, Mark M.

AU - Block, Stan

AU - Blumer, Jeffrey L.

AU - Boehm, Frederick P.

AU - Brayden, Robert

AU - Bromberg, Kenneth

AU - Buttler, John L.

AU - Chatterjee, Archana

AU - Conti, Ralph

AU - Coury, Daniel L.

AU - Danhauer, David E.

AU - Daum, Robert S.

AU - Dennehy, Penelope

AU - Dionne, Marc

AU - Eckert, Buckley

AU - Edwards, Kathryn M.

AU - Ford, Robert V.

AU - Fries, Stephen M.

AU - Goessler, Mary C.

AU - Greenberg, David P.

AU - Guerra, Fernando A.

AU - Guerrero, Juan

AU - Halperin, Scott

AU - Henderson, Frederick W.

AU - Hornick, Richard

AU - Iwaishi, Louise K.

AU - Johnson, Candice E.

AU - Jones, Ronald C.

AU - Karasov, Robert

AU - Law, Barbara

AU - Leader, Joseph

AU - Lebel, Mark

AU - Leiberman, Jay

AU - Lepow, Martha

AU - Luber, Stephen

AU - Marchant, Colin

AU - Marshall, Gary S.

AU - Matson, David O.

AU - Meissner, H. Cody

AU - Milnes, Philip D.

AU - Moore, William

AU - Nachman, Sharon A.

AU - Nauert, Beth

AU - Perrin, Keith

AU - Pollara, Bernard

AU - Rathore, Mobeen H.

AU - Rees, William C.

AU - Reisinger, Keith S.

AU - Rennels, Margaret

AU - Rothstein, Edward

AU - Rudoy, Raul

AU - Russell, Margaret

AU - Ryan, Michael E.

AU - Sawyer, Mark

AU - Senders, Shelly D.

AU - Shapiro, Steven A.

AU - Sher, Lawrence

AU - Shinefield, Henry

AU - Silas, Peter E.

AU - Sperling, Malcolm J.

AU - Stewart, Tracy

AU - Sullivan, Bradley

AU - Taylor, James A.

AU - Thompson, Steven M.

AU - Troutman, James L.

AU - Vaughn, Katherine F.

AU - Venters, Charmaine L.

AU - Walter, Emmanuel

AU - Watson, Barbara

AU - Werzberger, Alan

AU - Wheeler, J. Gary

AU - Williams, Karen R.

AU - Yeiser, Michael F.

AU - Yogev, Ram

N1 - Funding Information: Drs. Black, Shinefield, and Reisinger are speakers for Merck & Co., Inc. and receive research funding from Merck & Co., Inc. Doctors Marchant and Sullivan as well as the Study Group for ProQuad® participated in these research studies that were sponsored by Merck & Co., Inc.

PY - 2006

Y1 - 2006

N2 - Background: A combination measles, mumps, rubella, and varicella vaccine (ProQuad®, Merck & Co., Inc, West Point, PA) was evaluated in five clinical trials. Use of ProQuad® would result in fewer injections for children and would facilitate universal immunization against all four diseases. Objective: To describe the combined results obtained from the studies conducted dur-ing the clinical development program for ProQuad®. Methods: A total of 5833 healthy children, 12-23 months of age, and 399 healthy children, 4-6 years of age, received 1 or 2 doses of ProQuad® in five controlled clinical trials. M-M-R®II and VARIVAX® were used as the control for most studies. Safety was evaluated for six weeks postvaccination and immunogenicity was assessed six weeks after each dose by a sensitive assay (ELISA or gpELISA). Results: A single dose of ProQuad® in 12- to 23-month-old children was shown to be as immunogenic as a single dose of M-M-R®II and VARIVAX® and was generally well tolerated. ProQuad® can be used concomitantly with other vaccines (hepatitis B and Haemophilus influenzae b). A higher rate of fever was reported after 1 dose of ProQuad® compared to M-M-R®II and VARIVAX®, but fever episodes were transient without long-term sequelae. Both a 2-dose regimen of ProQuad® in 12- to 23-month-olds and use of ProQuad® in place of M-M-R®II at 4-6 years were shown to be immunogenic and well tolerated. The incidence of adverse experiences following a second dose of ProQuad® was lower than that following the initial dose. Conclusions: A single dose of ProQuad® is as immunogenic as M-M-R®II and VARIVAX® and is well tolerated in a 1- or 2-dose schedule. ProQuad® should easily fit into the routine immunization schedule.

AB - Background: A combination measles, mumps, rubella, and varicella vaccine (ProQuad®, Merck & Co., Inc, West Point, PA) was evaluated in five clinical trials. Use of ProQuad® would result in fewer injections for children and would facilitate universal immunization against all four diseases. Objective: To describe the combined results obtained from the studies conducted dur-ing the clinical development program for ProQuad®. Methods: A total of 5833 healthy children, 12-23 months of age, and 399 healthy children, 4-6 years of age, received 1 or 2 doses of ProQuad® in five controlled clinical trials. M-M-R®II and VARIVAX® were used as the control for most studies. Safety was evaluated for six weeks postvaccination and immunogenicity was assessed six weeks after each dose by a sensitive assay (ELISA or gpELISA). Results: A single dose of ProQuad® in 12- to 23-month-old children was shown to be as immunogenic as a single dose of M-M-R®II and VARIVAX® and was generally well tolerated. ProQuad® can be used concomitantly with other vaccines (hepatitis B and Haemophilus influenzae b). A higher rate of fever was reported after 1 dose of ProQuad® compared to M-M-R®II and VARIVAX®, but fever episodes were transient without long-term sequelae. Both a 2-dose regimen of ProQuad® in 12- to 23-month-olds and use of ProQuad® in place of M-M-R®II at 4-6 years were shown to be immunogenic and well tolerated. The incidence of adverse experiences following a second dose of ProQuad® was lower than that following the initial dose. Conclusions: A single dose of ProQuad® is as immunogenic as M-M-R®II and VARIVAX® and is well tolerated in a 1- or 2-dose schedule. ProQuad® should easily fit into the routine immunization schedule.

KW - Combination vaccines

KW - Measles

KW - Mumps

KW - Rubella

KW - Varicella

UR - http://www.scopus.com/inward/record.url?scp=33751202162&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33751202162&partnerID=8YFLogxK

U2 - 10.4161/hv.2.5.3246

DO - 10.4161/hv.2.5.3246

M3 - Article

C2 - 17035730

AN - SCOPUS:33751202162

SN - 1554-8600

VL - 2

SP - 205

EP - 214

JO - Human vaccines

JF - Human vaccines

IS - 5

ER -

Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad®)

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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