Safety, reactogenicity and immunogenicity of the live attenuated combined measles, mumps and rubella vaccine containing the RIT 4385 mumps strain in healthy Singaporean children.

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 degrees 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.