• Vol. 36 No. 12, 969–973
  • 15 December 2007

Safety, Reactogenicity and Immunogenicity of the Live Attenuated Combined Measles, Mumps and Rubella Vaccine Containing the RIT 4385 Mumps Strain in Healthy Singaporean Children

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ABSTRACT

Introduction: Measles, mumps and rubella (MMR) are viral infections causing significant mortality and morbidity for which effective and safe vaccines are available. The safety, reactogenicity and immunogenicity of a combined MMR vaccine when administered to healthy Singaporean children were evaluated in this study. Materials and Methods: A total of 150 children aged 12 to 18 months were vaccinated in this open, single-group, single-centre study [209762/147]. Solicited local and general symptoms reported within 4 days of vaccination and fever, parotid/salivary gland swelling and signs of meningism in the 43 days following vaccination were recorded using diary cards. Serious adverse events occurring during the study period were monitored. Immunogenicity was assessed at 42 days post-vaccination. Results: Redness (8.7%) and pain (7.2%) at injection site were the most commonly reported solicited local symptoms during the 4-day follow-up period after vaccination. Percentage of subjects reporting drowsiness, irritability and loss of appetite during the 4-day follow-up after vaccination was 7.2%, 8% and 7.2%, respectively. None of the solicited symptoms reported during the 4-day follow-up period was of grade “3” intensity. Fever (42.8%) was the most commonly reported solicited general symptom, with 5.1% of the children reporting fever >39.0°C (axillary). No serious adverse events considered to be related to vaccination were reported. Seroconversion rates were 100% for measles and rubella antibodies and 98.1% for mumps antibodies. Conclusions: GlaxoSmithKline Biologicals’ MMR vaccine was shown to be well tolerated and highly immunogenic when used in Singaporean children 12 to 18 months of age.


Measles, mumps and rubella (MMR) are contagious viral diseases associated with high mortality and morbidity, often linked with severe complications. Globally, measles remains the main cause of vaccine-preventable morbidity and mortality in children. This is true even in the Western Pacific region, despite the fact that immunisation has reduced deaths by 95% compared with the pre-vaccine era. In 2003, there were more than 100,000 measles cases reported in this region.1 The high incidence of mortality and complications associated with measles prompted the World Health Organization (WHO) to target measles for eradication through vaccination and to recommend offering all children 2 doses of measles or measles-containing vaccines. This “second opportunity” measles immunisation strategy,2 now adopted by most industrialised and many developing countries, is aimed at improving vaccination coverage in childhood, thereby achieving high herd immunity against measles. It also plays an important role in increasing the proportion of the population with lifelong protection against measles, as boosting through natural infection gradually disappears. Vaccination coverage of at least 95% for the first dose and at least 80% for the second dose has been listed by a panel of experts as 1 of 5 indicators of progress towards regional elimination of measles.3

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