Format

Send to

Choose Destination
J Pediatric Infect Dis Soc. 2019 Mar 8. pii: piz010. doi: 10.1093/jpids/piz010. [Epub ahead of print]

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.

Author information

1
Kaiser Permanente Vaccine Study Center, Oakland, California.
2
GlaxoSmithKline, Philadelphia, Pennsylvania.
3
GlaxoSmithKline, Wavre, Belgium.
4
Department of Infectious Diseases, Instituto Nacional de Pediatría, Mexico City, Mexico.
5
Fundacion para el Fomento de la Investigacion Sanitaria y Biomedica (FISABIO-Public Health), Valencia, Spain.
6
Vaccine Research Center, University of Tampere, Finland.
7
Laboratorio de Microbiología, Hospital General de Durango, Mexico.
8
Department of Pediatrics, SUNY Upstate Medical University, Syracuse, New York.
9
Department of Pediatrics, University of Louisville School of Medicine, Kentucky.
10
Wee Care Pediatrics, Layton, Utah.
11
Sealy Center for Vaccine Development, University of Texas, Galveston.
12
Jordan Ridge Kids & Teens, West Jordan, Utah.
13
Department of Pediatrics, University of North Texas Health Science Centre, Fort Worth.
14
Pediatric Pulmonary Division, Rainbow Babies and Children's Hospital, Cleveland, Ohio.
15
Puerto Rico Clinical and Translational Research Consortium, San Juan.
16
Department of Pediatrics, Children's Hospital at Montefiore, Bronx, New York.
17
Department of Pediatrics, University of Cincinnati College of Medicine and Pediatric Associates of Mt. Carmel, Inc, Ohio.
18
GlaxoSmithKline, Rockville, Maryland.

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.

KEYWORDS:

vaccine; immunogenicity; safety

PMID:
30849175
DOI:
10.1093/jpids/piz010

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center