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Clinical Trial
. 2020 Apr 30;9(2):194-201.
doi: 10.1093/jpids/piz010.

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  1 , Remon Abu-Elyazeed  2 , Michael Povey  3 , Mercedes Macias Parra  4 , Javier Diez-Domingo  5 , Anitta Ahonen  6 , Tiina Korhonen  6 , Juan-Carlos Tinoco  7 , Leonard Weiner  8 , Gary S Marshall  9 , Peter E Silas  10 , Kwabena O Sarpong  11 , Keith P Ramsey  12 , John A Fling  13 , David Speicher  14 , Maribel Campos  15 , Iona Munjal  16 , Christopher Peltier  17 , Timo Vesikari  6 , Carmen Baccarini  2 , Adrian Caplanusi  3 , Paul Gillard  3 , Stephane Carryn  3 , Ouzama Henry  18
Affiliations
Clinical Trial

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 et al. J Pediatric Infect Dis Soc. .

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.

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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.
See this image and copyright information in PMC

References

    1. Food and Drug Administration. M-M-R II: package insert. Available at: https://www.fda.gov/downloads/BiologicsBloodVaccines/UCM123789.pdf. Accessed April 28, 2018.
    1. Centers for Disease Control and Prevention. Measles—United States, 2000. MMWR Morb Mortal Wkly Rep 2002; 51:120–3. - PubMed
    1. Centers for Disease Control and Prevention. Chapter 20: rubella. In: Hamborsky J, Kroger A, Wolfe S, eds. The Pink Book: Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th ed. Washington DC: Public Health Foundation; 2015: pp 325–40.
    1. Centers for Disease Control and Prevention. Mumps cases and outbreaks. Available at: https://www.cdc.gov/mumps/outbreaks.html. Accessed March 13, 2018.
    1. Centers for Disease Control and Prevention. Measles cases and outbreaks. Available at: https://www.cdc.gov/measles/cases-outbreaks.html. Accessed October 13, 2017.

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