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Clinical Trial
. 2015 Dec;4(4):339-48.
doi: 10.1093/jpids/piu081. Epub 2014 Aug 7.

Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12-15 Months

Maurice A Mufson  1 , Clemente Diaz  2 , Michael Leonardi  3 , Christopher J Harrison  4 , Stanley Grogg  5 , Antonio Carbayo  6 , Simon Carlo-Torres  7 , Robert JeanFreau  8 , Ana Quintero-Del-Rio  9 , Gisele Bautista  10 , Michael Povey  11 , Christopher Da Costa  12 , Ouzama Nicholson  12 , Bruce L Innis  12
Affiliations
Clinical Trial

Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12-15 Months

Maurice A Mufson et al. J Pediatric Infect Dis Soc. 2015 Dec.

Abstract

Background: M-M-R(TM)II (MMRII; Merck & Co) is currently the only measles-mumps-rubella (MMR) vaccine licensed in the United States. Another licensed vaccine would reinforce MMR supply. This study assessed the immunogenicity of a candidate vaccine (Priorix(TM), GlaxoSmithKline Vaccines [MMR-RIT]) when used as a first dose among eligible children in the United States.

Methods: In this exploratory Phase-2, multicenter, observer-blind study, 1220 healthy subjects aged 12-15 months were randomized (3:3:3:3) and received 1 dose of 1 of 3 MMR-RIT lots with differing mumps virus titers (MMR-RIT-1 [4.8 log10]; MMR-RIT-2 [4.1 log10]; MMR-RIT-3 [3.7 log10] CCID50) or MMRII co-administered with hepatitis A vaccine (HAV), varicella vaccine (VAR) and 7-valent pneumococcal conjugate vaccine (PCV7). Immune response to measles, mumps, and rubella viruses was evaluated at Day 42 post-vaccination. Incidence of solicited injection site, general, and serious adverse events was assessed.

Results: Seroresponse rates for MMR vaccine viral components in MMR-RIT lots were 98.3-99.2% (measles), 89.7-90.7% (mumps), and 97.5-98.8% (rubella), and for MMRII were 99.6%, 91.1%, and 100%, respectively. Immune responses to HAV, VAR, and PCV7 were similar when co-administered with any of the 3 MMR-RIT lots or MMRII. There were no apparent differences in solicited or serious adverse events among the 4 groups.

Conclusions: Immune responses were above threshold levels for projected protection against the 3 viruses from MMR-RIT lots with differing mumps virus titers. MMR-RIT had an acceptable safety profile when co-administered with HAV, VAR, and PCV7.

Clinical trials registration: NCT00861744; etrack; 111870.

Keywords: co-administration; immunogenicity; measles; mumps; rubella.

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Figures

Figure 1.
Figure 1.
Disposition of subjects in the total vaccinated cohort (TVC) (enrolled = 1259 subjects, randomized = 1224 subjects, vaccinated = 1220 subjects). Abbreviations: MMR, measles-mumps-rubella; SAE, serious adverse event; ATP, according-to-protocol.
Figure 2.
Figure 2.
Prevalence of any fever from Day 0 to Day 42 after vaccination (total vaccinated cohort). Abbreviation: MMR, measles-mumps-rubella.
See this image and copyright information in PMC

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