Active Safety Monitoring of Measles-Mumps-Rubella Vaccine in the National Immunisation Programme of Sri Lanka

Objectives:This study was designed to report incidenceand characteristics of selected adverse events followingimmunisation which have consistent causal association(AEFIc) with Measles-Mumps-Rubella (MMR) vaccinationgiven at the age of one year in the National ImmunisationProgramme of Sri Lanka.Methods:The data presented here were obtained from acohort event monitoring study. It was carried out in the JaffnaRegional Directorate of Health Services area from November2012 to December 2014. A representative sample of 3002infants who received MMR immunisation were activelyfollowed up for adverse events (AE) using over the phoneinterviews, self-reporting, and home or hospital visits up to45 days. All AEs were reviewed by two investigatorsindependently in two step-wise processes to detect theAEFIc. Seven AEFIc were detected using standard casedefinitions and onset time limit criteria. They were subjectedto further analysis to describe the incidence rates andcharacteristics.Results:Of the 2398 (80%) infants who completedfollow up of 45 days, 1321 infants experienced 2621AEFI. Of them 209 were classified as AEFIc. Incidence ofAEFIc was 87/ 1000 immunisation. They were mainly nonseriousand resolved completely. There were no fatalor life threatening AEFIs. Incidence per 1000immunisations; allergic reactions 0.83, injection sitereactions 4.58, fever100.4° F or lasting more than  3 days9.59, macular papular rash 2.92, parotitis 2.92 andgeneralised convulsions 1.25.Conclusions:The MMR vaccine used in NIP of Sri Lanka hadlow incidence of AEFIc and were mainly non-serious innature.