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
Por:
Klein, N, Abu-Elyazeed, R, Povey, M, Macias Parra, M, Diez-Domingo, J, Ahonen, A, Korhonen, T, Tinoco, J, Weiner, L, Marshall, G, Silas, P, Sarpong, K, Ramsey, K, Fling, J, Speicher, D, Campos, M, Munjal, I, Peltier, C, Vesikari, T, Baccarini, C, Caplanusi, A, Gillard, P, Carryn, S and Henry, O
Publicada:
1 jun 2020
Ahead of Print:
8 mar 2019
Resumen:
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.
Filiaciones:
Klein, N:
Kaiser Permanente Vaccine Study Center, Oakland, California
Abu-Elyazeed, R:
GlaxoSmithKline, Philadelphia, Pennsylvania
Povey, M:
GlaxoSmithKline, Wavre, Belgium
Macias Parra, M:
Department of Infectious Diseases, Instituto Nacional de Pediatría, Mexico City, Mexico
:
Fundacion para el Fomento de la Investigacion Sanitaria y Biomedica (FISABIO-Public Health), Valencia, Spain
Ahonen, A:
Vaccine Research Center, University of Tampere, Finland
Korhonen, T:
Vaccine Research Center, University of Tampere, Finland
Tinoco, J:
Laboratorio de Microbiología, Hospital General de Durango, Mexico
Weiner, L:
Department of Pediatrics, SUNY Upstate Medical University, Syracuse, New York
Marshall, G:
Department of Pediatrics, University of Louisville School of Medicine, Kentucky
Silas, P:
Wee Care Pediatrics, Layton, Utah
Sarpong, K:
Sealy Center for Vaccine Development, University of Texas, Galveston
Ramsey, K:
Jordan Ridge Kids Teens, West Jordan, Utah
Fling, J:
Department of Pediatrics, University of North Texas Health Science Centre, Fort Worth
Speicher, D:
Pediatric Pulmonary Division, Rainbow Babies and Children's Hospital, Cleveland, Ohio
Campos, M:
Puerto Rico Clinical and Translational Research Consortium, San Juan
Munjal, I:
Department of Pediatrics, Children's Hospital at Montefiore, Bronx, New York
Peltier, C:
Department of Pediatrics, University of Cincinnati College of Medicine and Pediatric Associates of Mt. Carmel, Inc, Ohio
Vesikari, T:
Vaccine Research Center, University of Tampere, Finland
Baccarini, C:
GlaxoSmithKline, Philadelphia, Pennsylvania
Caplanusi, A:
GlaxoSmithKline, Wavre, Belgium
Gillard, P:
GlaxoSmithKline, Wavre, Belgium
Carryn, S:
GlaxoSmithKline, Wavre, Belgium
Henry, O:
GlaxoSmithKline, Rockville, Maryland
Green Published, hybrid
|