{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T04:49:36Z","timestamp":1790225376985,"version":"4.1.0"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2019,3,8]],"date-time":"2019-03-08T00:00:00Z","timestamp":1552003200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,4,30]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>MMR II (M-M-R II [Merck &amp; 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.1093\/jpids\/piz010","type":"journal-article","created":{"date-parts":[[2019,2,28]],"date-time":"2019-02-28T20:24:02Z","timestamp":1551385442000},"page":"194-201","source":"Crossref","is-referenced-by-count":20,"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"],"prefix":"10.1093","volume":"9","author":[{"given":"Nicola P","family":"Klein","sequence":"first","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center, Oakland, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Remon","family":"Abu-Elyazeed","sequence":"first","affiliation":[{"name":"GlaxoSmithKline, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Povey","sequence":"first","affiliation":[{"name":"GlaxoSmithKline, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mercedes","family":"Macias Parra","sequence":"first","affiliation":[{"name":"Department of Infectious Diseases, Instituto Nacional de Pediatr\u00eda, Mexico City, Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Diez-Domingo","sequence":"first","affiliation":[{"name":"Fundacion para el Fomento de la Investigacion Sanitaria y Biomedica (FISABIO-Public Health), Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anitta","family":"Ahonen","sequence":"first","affiliation":[{"name":"Vaccine Research Center, University of Tampere, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiina","family":"Korhonen","sequence":"first","affiliation":[{"name":"Vaccine Research Center, University of Tampere, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan-Carlos","family":"Tinoco","sequence":"first","affiliation":[{"name":"Laboratorio de Microbiolog\u00eda, Hospital General de Durango, Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonard","family":"Weiner","sequence":"first","affiliation":[{"name":"Department of Pediatrics, SUNY Upstate Medical University, Syracuse, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary S","family":"Marshall","sequence":"first","affiliation":[{"name":"Department of Pediatrics, University of Louisville School of Medicine, Kentucky"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter E","family":"Silas","sequence":"first","affiliation":[{"name":"Wee Care Pediatrics, Layton, Utah"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kwabena O","family":"Sarpong","sequence":"first","affiliation":[{"name":"Sealy Center for Vaccine Development, University of Texas, Galveston"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith P","family":"Ramsey","sequence":"first","affiliation":[{"name":"Jordan Ridge Kids & Teens, West Jordan, Utah"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John A","family":"Fling","sequence":"first","affiliation":[{"name":"Department of Pediatrics, University of North Texas Health Science Centre, Fort Worth"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Speicher","sequence":"first","affiliation":[{"name":"Pediatric Pulmonary Division, Rainbow Babies and Children\u2019s Hospital, Cleveland, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maribel","family":"Campos","sequence":"first","affiliation":[{"name":"Puerto Rico Clinical and Translational Research Consortium, San Juan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iona","family":"Munjal","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Children\u2019s Hospital at Montefiore, Bronx, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Peltier","sequence":"first","affiliation":[{"name":"Department of Pediatrics, University of Cincinnati College of Medicine and Pediatric Associates of Mt. 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