학술논문
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.
Document Type
Article
Author
Klein, Nicola P; Abu-Elyazeed, Remon; Povey, Michael; Parra, Mercedes Macias; 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
Source
Subject
*ENZYME-linked immunosorbent assay
*IMMUNOGLOBULINS
*RESEARCH funding
*SAFETY
*STATISTICAL sampling
*MMR vaccines
*RANDOMIZED controlled trials
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Language
ISSN
2048-7193
Abstract
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. [ABSTRACT FROM AUTHOR]