Profil Keamanan setelah Pemberian Dosis Primer Vaksin Pentabio® pada Bayi di Indonesia

Abstract

Vaksin Hib mulai digunakan pada Pogram Imunisasi Nasional sejak tahun 2013 secara bertahap dan di seluruh Indonesia mulai tahun 2014 dalam bentuk vaksin kombinasi DTP/HB/Hib (Pentabio®), yang memberikan  kekebalan terhadap difteria, pertusis, tetanus, hepatitis B, dan Haemophilus influenzae tipe b. Studi ini menilai reaksi sitemik, reaksi lokal, dan reaksi yang serius pascaimunisasi dengan Pentabio®. Sebanyak 4.000 bayi penerima vaksin Pentabio®bergabung dalam studi ini. Reaksi yang timbul dicatat pada kartu harian oleh petugas yang sudah dilatih. Vaksin Pentabio®yang diamati pada PMS ini menggunakan vaksin rutin dari Program Imunisasi Nasional dalam waktu pengamatan 28 hari di empat propinsi, yaitu Nusa Tenggara Barat, Bali, Yogyakarta, dan Jawa Barat pada periode Mei–Desember 2014. Sebanyak 3.978 data dapat dianalisis karena 22 di antaranya tidak memberikan informasi yang valid. Reaksi sistemik yang paling banyak timbul adalah demam 0,85% pada 30 menit pertama, dan meningkat menjadi 14,03% pada satu hari pascaimunisasi, kemudian sembuh pada hari berikutnya. Reaksi lokal yang paling sering timbul adalah nyeri pada tempat suntikan pada 67,6% subjek pada 30 menit setelah imunisasi, dan meningkat menjadi 87,23% pada 1 hari pascaimunisasi namun sembuh pada hari berikutnya. Mayoritas nyeri yang timbul adalah kategori ringan. Tidak ditemukan kejadian ikutan pascaimunisasi serius selama pengamatan. Simpulan, reaksi lokal dan sistemik pascaimunisasi dengan Pentabio® dapat ditoleransi pada bayi. [MKB. 2017;49(2):86–93]
 
Kata kunci: Bayi, Pentabio®, post marketing surveillance, reaksi lokal, reaksi sistemik
 

Safety Profile Following Pentabio® Primary Dose Vaccination in Indonesian Infants
 
Since 2013 Indonesian Expanded Program on Immunization (EPI) has  graduallyincluded Hib vaccine into routine EPI schedule in four provinces and has established the vaccine inclusion in the the nationwide program through integration of Hib vaccine into existing DTP/HB vaccine in the form of pentavalent vaccine (DTP/HB/Hib). Pentabio® vaccine is given to provide protection against diphtheria, tetanus, pertussis, hepatitis B, and Hib infection in infants and children under 5 years old.  The objective of this study was to assess the systemic reactions, local reactions, and any serious adverse event after Pentabio® immunization. About 4,000 infants were involved in this study. Systemic and local reactions were recorded on diary cards by trained health care provider. Pentabio® vaccines in this PMS were obtained from the National Immunization Program within 28 days of observation in four provinces, West Nusa Tenggara, Bali, Yogyakarta, and West Java in May–December 2014. In total, 3,978 infants were analyzed, while the other 22 forms were not included due to incomplete information. The most common systemic reaction was fever, found in 0.85% of the subjects at 30 minutes after injection, and increased to 14.03% at day 1 (one) after immunization, which disappeared the day after. The most common local reaction was pain, which was found in 67.6% subjects at 30 minutes after injection, and increased to 87.23% at day 1 (one) after immunization to disappear the day after. The intensity of the pain was mostly mild. No serious adverse event following immunization found during observation. [MKB. 2017;49(2):86–93]
 
Key words: Infants, local reactions, Pentabio®, post marketing surveillance, systemic reactions