Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study

Background. MMR II (M-M-R II [Merck & Co, Inc.]) is currently the only measles, mumps, and rubella (MMR) vaccine licensed in the United States. A second MMR vaccine would mitigate the potential risk of vaccine supply shortage or delay. In this study, we assessed the immunogenicity and safety of...

Descripción completa

Detalles Bibliográficos
Autores: Klein, Nicola P, Abu-Elyazeed, Remon, Povey, Michael, Macias Parra, Mercedes, Diez-Domingo, Javier, Ahonen, Anitta, Korhonen, Tiina, Tinoco, Juan-Carlos, Weiner, Leonard, Marshall, Gary S, Silas, Peter E, Sarpong, Kwabena O, Ramsey, Keith P, Fling, John A, Speicher, David, Campos, Maribel, Munjal, Iona, Peltier, Christopher, Vesikari, Timo, Baccarini, Carmen, Caplanusi, Adrian, Gillard, Paul, Carryn, Stephane, Henry, Ouzama
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p3323
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/3323
Access Level:acceso abierto
Palabra clave:immunogenicity
measles-mumps-rubella vaccine
safety
id ES_69e67b6baf0583c88ce5fb0d8ac72d27
oai_identifier_str oai:fisabio.fundanetsuite.com:p3323
network_acronym_str ES
network_name_str España
repository_id_str
spelling Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency StudyKlein, Nicola PAbu-Elyazeed, RemonPovey, MichaelMacias Parra, MercedesDiez-Domingo, JavierAhonen, AnittaKorhonen, TiinaTinoco, Juan-CarlosWeiner, LeonardMarshall, Gary SSilas, Peter ESarpong, Kwabena ORamsey, Keith PFling, John ASpeicher, DavidCampos, MaribelMunjal, IonaPeltier, ChristopherVesikari, TimoBaccarini, CarmenCaplanusi, AdrianGillard, PaulCarryn, StephaneHenry, Ouzamaimmunogenicitymeasles-mumps-rubella vaccinesafetyBackground. MMR II (M-M-R II [Merck & Co, Inc.]) is currently the only measles, mumps, and rubella (MMR) vaccine licensed in the United States. A second MMR vaccine would mitigate the potential risk of vaccine supply shortage or delay. In this study, we assessed the immunogenicity and safety of another MMR vaccine (MMR-RIT [Priorix, GlaxoSmithKline]) compared with those of the MMR II in 12- to 15-month-old children who received it as a first dose. Methods. In this phase III, observer-blinded, noninferiority, lot-to-lot consistency clinical trial (ClinicalTrials.gov identifier NCT01702428), 5003 healthy children were randomly assigned to receive 1 dose of MMR-RIT (1 of 3 production lots) or MMR II along with other age-recommended routine vaccines. We evaluated the immunogenicity of all vaccines in terms of antibody concentrations (by using an enzyme-linked immunosorbent assay or electrochemiluminescence assay) and/or seroresponse rates 43 days after vaccination. We also assessed the reactogenicity and safety of the vaccines. Results. Immunoresponses after vaccination with MMR-RIT were robust and noninferior to those after vaccination with the MMR II. Immunogenicity of the 3 production lots of MMR-RIT was consistent; more than 97% of the children had a seroresponse to MMR components. The coadministered vaccines elicited similar immunoresponses in the MMR-RIT and MMR II groups. Both MMR vaccines resulted in comparable reactogenicity profiles, and no safety concerns were detected. Conclusions. If licensed, the MMR-RIT could provide a valid option for the prevention of measles, mumps, and rubella in children in the United States and would reduce potential risks of a vaccine shortage.OXFORD UNIV PRESS2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/3323Journal of the Pediatric Infectious Diseases SocietyISSN: 20487193ISSNe: 20487207reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p33232026-06-11T12:45:17Z
dc.title.none.fl_str_mv Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study
title Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study
spellingShingle Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study
Klein, Nicola P
immunogenicity
measles-mumps-rubella vaccine
safety
title_short Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study
title_full Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study
title_fullStr Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study
title_full_unstemmed Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study
title_sort Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study
dc.creator.none.fl_str_mv Klein, Nicola P
Abu-Elyazeed, Remon
Povey, Michael
Macias Parra, Mercedes
Diez-Domingo, Javier
Ahonen, Anitta
Korhonen, Tiina
Tinoco, Juan-Carlos
Weiner, Leonard
Marshall, Gary S
Silas, Peter E
Sarpong, Kwabena O
Ramsey, Keith P
Fling, John A
Speicher, David
Campos, Maribel
Munjal, Iona
Peltier, Christopher
Vesikari, Timo
Baccarini, Carmen
Caplanusi, Adrian
Gillard, Paul
Carryn, Stephane
Henry, Ouzama
author Klein, Nicola P
author_facet Klein, Nicola P
Abu-Elyazeed, Remon
Povey, Michael
Macias Parra, Mercedes
Diez-Domingo, Javier
Ahonen, Anitta
Korhonen, Tiina
Tinoco, Juan-Carlos
Weiner, Leonard
Marshall, Gary S
Silas, Peter E
Sarpong, Kwabena O
Ramsey, Keith P
Fling, John A
Speicher, David
Campos, Maribel
Munjal, Iona
Peltier, Christopher
Vesikari, Timo
Baccarini, Carmen
Caplanusi, Adrian
Gillard, Paul
Carryn, Stephane
Henry, Ouzama
author_role author
author2 Abu-Elyazeed, Remon
Povey, Michael
Macias Parra, Mercedes
Diez-Domingo, Javier
Ahonen, Anitta
Korhonen, Tiina
Tinoco, Juan-Carlos
Weiner, Leonard
Marshall, Gary S
Silas, Peter E
Sarpong, Kwabena O
Ramsey, Keith P
Fling, John A
Speicher, David
Campos, Maribel
Munjal, Iona
Peltier, Christopher
Vesikari, Timo
Baccarini, Carmen
Caplanusi, Adrian
Gillard, Paul
Carryn, Stephane
Henry, Ouzama
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv immunogenicity
measles-mumps-rubella vaccine
safety
topic immunogenicity
measles-mumps-rubella vaccine
safety
description Background. MMR II (M-M-R II [Merck & Co, Inc.]) is currently the only measles, mumps, and rubella (MMR) vaccine licensed in the United States. A second MMR vaccine would mitigate the potential risk of vaccine supply shortage or delay. In this study, we assessed the immunogenicity and safety of another MMR vaccine (MMR-RIT [Priorix, GlaxoSmithKline]) compared with those of the MMR II in 12- to 15-month-old children who received it as a first dose. Methods. In this phase III, observer-blinded, noninferiority, lot-to-lot consistency clinical trial (ClinicalTrials.gov identifier NCT01702428), 5003 healthy children were randomly assigned to receive 1 dose of MMR-RIT (1 of 3 production lots) or MMR II along with other age-recommended routine vaccines. We evaluated the immunogenicity of all vaccines in terms of antibody concentrations (by using an enzyme-linked immunosorbent assay or electrochemiluminescence assay) and/or seroresponse rates 43 days after vaccination. We also assessed the reactogenicity and safety of the vaccines. Results. Immunoresponses after vaccination with MMR-RIT were robust and noninferior to those after vaccination with the MMR II. Immunogenicity of the 3 production lots of MMR-RIT was consistent; more than 97% of the children had a seroresponse to MMR components. The coadministered vaccines elicited similar immunoresponses in the MMR-RIT and MMR II groups. Both MMR vaccines resulted in comparable reactogenicity profiles, and no safety concerns were detected. Conclusions. If licensed, the MMR-RIT could provide a valid option for the prevention of measles, mumps, and rubella in children in the United States and would reduce potential risks of a vaccine shortage.
publishDate 2020
dc.date.none.fl_str_mv 2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fisabio.portalinvestigacion.com/publicaciones/3323
url https://fisabio.portalinvestigacion.com/publicaciones/3323
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv OXFORD UNIV PRESS
publisher.none.fl_str_mv OXFORD UNIV PRESS
dc.source.none.fl_str_mv Journal of the Pediatric Infectious Diseases Society
ISSN: 20487193
ISSNe: 20487207
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869410062706933760
score 15,198674

Similares en LA Referencia