Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin

Gabriela Rüger; Giovanni Gabutti; Hans Rümke; Lars Rombo; Enrique Bernaola; Javier Diez-Domingo; Federico Martinon-Torres; Birthe Høgh; Antreas Konstantopoulos; Anne Fiquet; Stéphane Thomas; Cécile Eymin; Martine Baudin

doi:10.1097/inf.0b013e318267fd8b

Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin

Gabriela Rüger, Giovanni Gabutti, Hans Rümke, Lars Rombo, Enrique Bernaola, Javier Diez-Domingo, Federico Martinon-Torres, Birthe Høgh, Antreas Konstantopoulos, Anne Fiquet, Stéphane Thomas, Cécile Eymin, Martine Baudin

7 Citationer (Scopus)

Abstract

BACKGROUND: ProQuad, a vaccine containing antigens from M-M-RVAXPRO (measles, mumps and rubella vaccine) and VARIVAX (varicella vaccine), is indicated for simultaneous vaccination against measles, mumps, rubella and varicella (MMRV) in individuals from 12 months of age. To eliminate blood-derived products of human origin from the manufacturing process of the MMRV vaccine, recombinant human albumin was selected as a replacement for human serum albumin.

METHODS: This open-label, multicenter clinical trial (clinicaltrials.gov identifier NCT00560755) was designed to describe the safety profile of a 2-dose schedule of the MMRV vaccine at a 1-month interval in healthy children aged 12-22 months.

RESULTS: In total, 3388 children received at least 1 dose of the MMRV vaccine. Overall, 3376 (99.65%) children were included in the post-dose 1 safety analysis and 3342 (98.64%) in the post-dose 2 safety analysis. After doses 1 and 2, the frequencies of children experiencing solicited injection-site reactions (post-dose 1: erythema 14.31%; swelling 5.57% and pain 10.31%; post-dose 2: erythema 30.46%; swelling 13.23% and pain 11.49%), rashes of interest (post-dose 1: 11.4%; post-dose 2: 2.78%), vaccine-related nonserious systemic adverse events (post-dose 1: 34.86%; post-dose 2: 13.4%) and temperature ≥39.4 °C (post-dose 1: 25.24%; post-dose 2: 12.06%) were consistent with those observed in previous studies of the MMRV vaccine manufactured with human serum albumin. Neither serious allergic-type adverse events nor anaphylactic reactions were reported.

CONCLUSION: The results confirm the good safety profiles of MMRV and of measles, mumps and rubella vaccines manufactured with recombinant human albumin.

Originalsprog	Engelsk
Tidsskrift	The Pediatric Infectious Disease Journal
Vol/bind	31
Udgave nummer	11
Sider (fra-til)	1166-72
Antal sider	7
ISSN	0891-3668
DOI	https://doi.org/10.1097/inf.0b013e318267fd8b
Status	Udgivet - nov. 2012

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10.1097/inf.0b013e318267fd8b

Citationsformater

Rüger, G., Gabutti, G., Rümke, H., Rombo, L., Bernaola, E., Diez-Domingo, J., Martinon-Torres, F., Høgh, B., Konstantopoulos, A., Fiquet, A., Thomas, S., Eymin, C., & Baudin, M. (2012). Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin. The Pediatric Infectious Disease Journal, 31(11), 1166-72. https://doi.org/10.1097/inf.0b013e318267fd8b

Rüger, G, Gabutti, G, Rümke, H, Rombo, L, Bernaola, E, Diez-Domingo, J, Martinon-Torres, F, Høgh, B, Konstantopoulos, A, Fiquet, A, Thomas, S, Eymin, C & Baudin, M 2012, 'Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin', The Pediatric Infectious Disease Journal, bind 31, nr. 11, s. 1166-72. https://doi.org/10.1097/inf.0b013e318267fd8b

@article{abad859247da425a976c47b3f29e0f05,

title = "Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin",

abstract = "BACKGROUND: ProQuad, a vaccine containing antigens from M-M-RVAXPRO (measles, mumps and rubella vaccine) and VARIVAX (varicella vaccine), is indicated for simultaneous vaccination against measles, mumps, rubella and varicella (MMRV) in individuals from 12 months of age. To eliminate blood-derived products of human origin from the manufacturing process of the MMRV vaccine, recombinant human albumin was selected as a replacement for human serum albumin.METHODS: This open-label, multicenter clinical trial (clinicaltrials.gov identifier NCT00560755) was designed to describe the safety profile of a 2-dose schedule of the MMRV vaccine at a 1-month interval in healthy children aged 12-22 months.RESULTS: In total, 3388 children received at least 1 dose of the MMRV vaccine. Overall, 3376 (99.65%) children were included in the post-dose 1 safety analysis and 3342 (98.64%) in the post-dose 2 safety analysis. After doses 1 and 2, the frequencies of children experiencing solicited injection-site reactions (post-dose 1: erythema 14.31%; swelling 5.57% and pain 10.31%; post-dose 2: erythema 30.46%; swelling 13.23% and pain 11.49%), rashes of interest (post-dose 1: 11.4%; post-dose 2: 2.78%), vaccine-related nonserious systemic adverse events (post-dose 1: 34.86%; post-dose 2: 13.4%) and temperature ≥39.4 °C (post-dose 1: 25.24%; post-dose 2: 12.06%) were consistent with those observed in previous studies of the MMRV vaccine manufactured with human serum albumin. Neither serious allergic-type adverse events nor anaphylactic reactions were reported.CONCLUSION: The results confirm the good safety profiles of MMRV and of measles, mumps and rubella vaccines manufactured with recombinant human albumin.",

keywords = "Albumins/immunology, Chickenpox Vaccine/administration & dosage, Humans, Immunization Schedule, Infant, Measles-Mumps-Rubella Vaccine/administration & dosage, Recombinant Proteins, Vaccines, Combined/administration & dosage",

author = "Gabriela R{\"u}ger and Giovanni Gabutti and Hans R{\"u}mke and Lars Rombo and Enrique Bernaola and Javier Diez-Domingo and Federico Martinon-Torres and Birthe H{\o}gh and Antreas Konstantopoulos and Anne Fiquet and St{\'e}phane Thomas and C{\'e}cile Eymin and Martine Baudin",

year = "2012",

month = nov,

doi = "10.1097/inf.0b013e318267fd8b",

language = "English",

volume = "31",

pages = "1166--72",

journal = "Pediatric Infectious Disease Journal",

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publisher = "Lippincott Williams & Wilkins",

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TY - JOUR

T1 - Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin

AU - Rüger, Gabriela

AU - Gabutti, Giovanni

AU - Rümke, Hans

AU - Rombo, Lars

AU - Bernaola, Enrique

AU - Diez-Domingo, Javier

AU - Martinon-Torres, Federico

AU - Høgh, Birthe

AU - Konstantopoulos, Antreas

AU - Fiquet, Anne

AU - Thomas, Stéphane

AU - Eymin, Cécile

AU - Baudin, Martine

PY - 2012/11

Y1 - 2012/11

N2 - BACKGROUND: ProQuad, a vaccine containing antigens from M-M-RVAXPRO (measles, mumps and rubella vaccine) and VARIVAX (varicella vaccine), is indicated for simultaneous vaccination against measles, mumps, rubella and varicella (MMRV) in individuals from 12 months of age. To eliminate blood-derived products of human origin from the manufacturing process of the MMRV vaccine, recombinant human albumin was selected as a replacement for human serum albumin.METHODS: This open-label, multicenter clinical trial (clinicaltrials.gov identifier NCT00560755) was designed to describe the safety profile of a 2-dose schedule of the MMRV vaccine at a 1-month interval in healthy children aged 12-22 months.RESULTS: In total, 3388 children received at least 1 dose of the MMRV vaccine. Overall, 3376 (99.65%) children were included in the post-dose 1 safety analysis and 3342 (98.64%) in the post-dose 2 safety analysis. After doses 1 and 2, the frequencies of children experiencing solicited injection-site reactions (post-dose 1: erythema 14.31%; swelling 5.57% and pain 10.31%; post-dose 2: erythema 30.46%; swelling 13.23% and pain 11.49%), rashes of interest (post-dose 1: 11.4%; post-dose 2: 2.78%), vaccine-related nonserious systemic adverse events (post-dose 1: 34.86%; post-dose 2: 13.4%) and temperature ≥39.4 °C (post-dose 1: 25.24%; post-dose 2: 12.06%) were consistent with those observed in previous studies of the MMRV vaccine manufactured with human serum albumin. Neither serious allergic-type adverse events nor anaphylactic reactions were reported.CONCLUSION: The results confirm the good safety profiles of MMRV and of measles, mumps and rubella vaccines manufactured with recombinant human albumin.

AB - BACKGROUND: ProQuad, a vaccine containing antigens from M-M-RVAXPRO (measles, mumps and rubella vaccine) and VARIVAX (varicella vaccine), is indicated for simultaneous vaccination against measles, mumps, rubella and varicella (MMRV) in individuals from 12 months of age. To eliminate blood-derived products of human origin from the manufacturing process of the MMRV vaccine, recombinant human albumin was selected as a replacement for human serum albumin.METHODS: This open-label, multicenter clinical trial (clinicaltrials.gov identifier NCT00560755) was designed to describe the safety profile of a 2-dose schedule of the MMRV vaccine at a 1-month interval in healthy children aged 12-22 months.RESULTS: In total, 3388 children received at least 1 dose of the MMRV vaccine. Overall, 3376 (99.65%) children were included in the post-dose 1 safety analysis and 3342 (98.64%) in the post-dose 2 safety analysis. After doses 1 and 2, the frequencies of children experiencing solicited injection-site reactions (post-dose 1: erythema 14.31%; swelling 5.57% and pain 10.31%; post-dose 2: erythema 30.46%; swelling 13.23% and pain 11.49%), rashes of interest (post-dose 1: 11.4%; post-dose 2: 2.78%), vaccine-related nonserious systemic adverse events (post-dose 1: 34.86%; post-dose 2: 13.4%) and temperature ≥39.4 °C (post-dose 1: 25.24%; post-dose 2: 12.06%) were consistent with those observed in previous studies of the MMRV vaccine manufactured with human serum albumin. Neither serious allergic-type adverse events nor anaphylactic reactions were reported.CONCLUSION: The results confirm the good safety profiles of MMRV and of measles, mumps and rubella vaccines manufactured with recombinant human albumin.

KW - Albumins/immunology

KW - Chickenpox Vaccine/administration & dosage

KW - Humans

KW - Immunization Schedule

KW - Infant

KW - Measles-Mumps-Rubella Vaccine/administration & dosage

KW - Recombinant Proteins

KW - Vaccines, Combined/administration & dosage

U2 - 10.1097/inf.0b013e318267fd8b

DO - 10.1097/inf.0b013e318267fd8b

M3 - Journal article

C2 - 22772170

SN - 0891-3668

VL - 31

SP - 1166

EP - 1172

JO - Pediatric Infectious Disease Journal

JF - Pediatric Infectious Disease Journal

IS - 11

ER -

Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin

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