Profil Keamanan Setelah Pemberian Dosis Primer Vaksin Pentabion pada bayi di Indonesia

Julitasari Sundoro, Kusnandi Rusmil, Mei Neni Sitaresmi, Arhana, I.G.G. Djelantik, Sri Rezeki Hadinegoro, Hindra Irawan Satari, Syafriyal, Novilia Sjafri Bachtiar, Rini Mulia Sari

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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.
Original languageIndonesian
Pages (from-to)86-93
JournalMajalah Kedokteran Bandung (MKB) Bandung Medical Journal
Issue number2
Publication statusPublished - 1 Jun 2017


  • Infants, local reactions, Pentabio®, post marketing surveillance, systemic reactions

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