A randomized comparative trial in order to assess the reactogenicity and immunogenicity of a new measles mumps rubella (MMR) vaccine when given as a first dose at 12-24 months of age

Southeast Asian J Trop Med Public Health. 1999 Sep;30(3):511-7.

Abstract

An open, randomized multi-center trial, involving 700 infants, was conducted in order to compare a new measles mumps rubella (MMR) vaccine, SB MMR (containing a Jeryl Lynn derived mumps strain RIT 4385) with a widely used vaccine, Merck MMR, when given to children between 12-24 months. Infants were divided between 2 groups; group 1 received SB MMR while group 2 received Merck MMR. Solicited local and general symptoms were recorded using diary cards and antibody levels were measured using ELISA assays. There was a significantly lower incidence of redness (p < 0.001) and swelling (p = 0.03) observed in group 1 compared with group 2. The incidence of all other solicited local and general symptoms were comparable between groups. In initially seronegative subjects equivalent seroconversion rates and post-vaccination GMTs were observed between groups. In conclusion, these results demonstrate that SB MMR is safe and well tolerated when given to children at this age range, and has an equivalent immunogenic profile compared to the widely used Merck MMR vaccine.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Analysis of Variance
  • Antibody Formation
  • Child, Preschool
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Fever / etiology
  • Humans
  • Infant
  • Male
  • Measles / immunology
  • Measles Vaccine / administration & dosage*
  • Measles Vaccine / adverse effects
  • Measles Vaccine / immunology
  • Measles-Mumps-Rubella Vaccine
  • Mumps / immunology
  • Mumps Vaccine / administration & dosage*
  • Mumps Vaccine / adverse effects
  • Mumps Vaccine / immunology
  • Philippines
  • Rubella / immunology
  • Rubella Vaccine / administration & dosage*
  • Rubella Vaccine / adverse effects
  • Rubella Vaccine / immunology
  • Seizures / etiology
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / adverse effects
  • Vaccines, Combined / immunology

Substances

  • Measles Vaccine
  • Measles-Mumps-Rubella Vaccine
  • Mumps Vaccine
  • Rubella Vaccine
  • Vaccines, Combined