title: Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12-15 Months.
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.
  
  
  BACKGROUND
  NCT00861744; etrack; 111870.
authors.affiliation: Department of Medicine, Joan C. Edwards School of Medicine, Marshall University, Huntington, West Virginia.
authors.forename: Maurice A
authors.initials: MA
authors.lastname: Mufson
authors.affiliation: School of Medicine, Medical Sciences Campus, University of Puerto Rico, San Juan.
authors.forename: Clemente
authors.initials: C
authors.lastname: Diaz
authors.affiliation: Palmetto Pediatrics PA, North Charleston, South Carolina.
authors.forename: Michael
authors.initials: M
authors.lastname: Leonardi
authors.affiliation: Children's Mercy Hospital and Clinics, and University of Missouri at Kansas City.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Harrison
authors.affiliation: Oklahoma State University, Center for Health Sciences, Tulsa.
authors.forename: Stanley
authors.initials: S
authors.lastname: Grogg
authors.affiliation: Full Health University Medical Clinic, Santa Ana, California.
authors.forename: Antonio
authors.initials: A
authors.lastname: Carbayo
authors.affiliation: Molecular Medicine Department, Hospital de La Concepcion, San German, Puerto Rico.
authors.forename: Simon
authors.initials: S
authors.lastname: Carlo-Torres
authors.affiliation: Benchmark Research, Metairie, Louisiana.
authors.forename: Robert
authors.initials: R
authors.lastname: JeanFreau
authors.affiliation: Pediatric Rheumatology Center of Puerto Rico, Bayamon.
authors.forename: Ana
authors.initials: A
authors.lastname: Quintero-Del-Rio
authors.affiliation: Reliance Institute of Clinical Research, Chino, California.
authors.forename: Gisele
authors.initials: G
authors.lastname: Bautista
authors.affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.
authors.forename: Michael
authors.initials: M
authors.lastname: Povey
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Christopher
authors.initials: C
authors.lastname: Da Costa
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Ouzama
authors.initials: O
authors.lastname: Nicholson
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Innis
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D019433:Chickenpox Vaccine / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000627:therapeutic use; D000069443:Heptavalent Pneumococcal Conjugate Vaccine / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D008297:Male; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012709:Serum Albumin; D014481:United States; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D022362:Hepatitis A Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D012709:Serum Albumin; D017778:Vaccines, Combined
keywords: co-administration; immunogenicity; measles; mumps; rubella