Protektivitas, Reaksi Lokal dan Sistemik setelah Imunisasi dengan Vaksin Td pada Anak Sekolah Dasar di Indonesia

Abstract

Td vaccine is given to provide protection to tetanus and diphtheria in children 7 years of age or above. The objectives of this study are to evaluate the reactions and immune response after 1 dose of Td vaccine. This study is a post marketing surveillance with a cohort design among elementary school students in East Java. Systemic and local reactions were recorded in diary cards untill 28 days after immunization. Blood was collected before and 28 days after immunization. Antibody titers were measured using double antigen ELISA with cut off protection rate >0,01 IU/ml. Observation were done between October 2010 to April 2011 which involved 2978 included 159 subjects for immune response group. In this study, fever was occured in 1,18%-2,45% subjects at the first three days with mild in intensity and resolved immediately without any medication. The most often local reaction was pain in 62,49% subjects at 30 minutes after injection, and increased to 83,38% at day 1 after immunization, and decreased the day after, with the intensity mostly were mild. No serious adverse reactions was found. 98,11% and 99,37% subjects were protected to diphtheria and tetanus, with the Geometric Mean Titer 1,2280 IU/mL (p=0,000) for anti-diphtheria and 10,6068 IU/mL (p=0.009) for anti-tetanus. In conclusion, Td vaccine is safe and immunogenic after 1 (one) dose in school age children, and there were no serious adverse event.

Keywords

• local reactions
• post marketing surveillance (PMS)
• systemic reactions
• Td vaccine