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

Nicola P Klein, Remon Abu-Elyazeed, Michael Povey, Mercedes Macias Parra, Javier Diez-Domingo, Anitta Ahonen, Tiina Korhonen, Juan-Carlos Tinoco, Leonard Weiner, Gary S Marshall, Peter E Silas, Kwabena O Sarpong, Keith P Ramsey, John A Fling, David Speicher, Maribel Campos, Iona Munjal, Christopher Peltier, Timo Vesikari, Carmen Baccarini, Adrian Caplanusi, Paul Gillard, Stephane Carryn, Ouzama Henry, Nicola P Klein, Remon Abu-Elyazeed, Michael Povey, Mercedes Macias Parra, Javier Diez-Domingo, Anitta Ahonen, Tiina Korhonen, Juan-Carlos Tinoco, Leonard Weiner, Gary S Marshall, Peter E Silas, Kwabena O Sarpong, Keith P Ramsey, John A Fling, David Speicher, Maribel Campos, Iona Munjal, Christopher Peltier, Timo Vesikari, Carmen Baccarini, Adrian Caplanusi, Paul Gillard, Stephane Carryn, Ouzama Henry

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.

© The Author(s) 2019. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society.

Figures

Figure 1.
Figure 1.
Flow diagram of the study participants. Abbreviations: ATP, according-to-protocol; N, number of children; n, number of children within the category.
Figure 2.
Figure 2.
Prevalence of fever from day 0 to day 42 after vaccination (total vaccinated cohort). For visualization purposes, the scale of the y axis is different in each graph.
Figure 3.
Figure 3.
Focus on the patient. Summary contextualizing the outcomes of the study for the convenience of health care professionals.

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