Protektivitas, Reaksi Lokal dan Sistemik Pascaimunisasi dengan Vaksin Campak (Bio Farma) dari Bets Vaksin yang Berbeda pada Anak Sekolah Dasar di Sumatera Barat

Abstract

Post Marketing Surveillance should be conducted periodically to monitor whether the quality of marketed products is still favorable. The objectives of this study were to evaluate the protectiveness, local reaction, and systemic reaction after receiving booster dose of measles vaccine from different batch numbers. This study was a cohort study on elementary students in West Sumatra. Subjects from Agam District received measles vaccine with a batch number of 250210 while subjects from Limapuluh Kota District received measles vaccine with a batch number of 253080. Blood samples were collected before and 28 days after immunization. Antibody titers were measured using neutralization assay with a protective level of >200 mIU/mL. Local and systemic reactions were recorded within 28 days after immunization. The observation was held from November 2010 to March 2011 and involved 336 students: 170 students from Agam District and 166 students from Limapuluh Kota District. There were 1.2% students who experienced fever in the first three days after immunization, and 1(0.6%) student experienced mild fever 14 days after immunization. The most common local reaction was redness in the injection site, contributing approximately 14.48%. There were no serious adverse events after immunization. About 96.99% and 96.77% students were protected against measles 28 days after immunization in Agam and Limapuluh Kota Districts with an increase in GMT from 329.66 IU/mL to 983.43 IU/mL and from 198.00 IU/mL to 535.10 IU/mL (p=0.000). In conclusion, both measles vaccine batches show good safety and immune response.

Keywords

• Local reaction
• measles
• Post Marketing Surveillance (PMS)
• systemic reaction
• vaccine