TY - JOUR
T1 - Profil Keamanan Setelah Pemberian Dosis Primer Vaksin Pentabion pada bayi di Indonesia
AU - Sundoro, Julitasari
AU - Rusmil, Kusnandi
AU - Sitaresmi, Mei Neni
AU - Arhana, null
AU - Djelantik, I.G.G.
AU - Hadinegoro, Sri Rezeki
AU - Satari, Hindra Irawan
AU - Syafriyal, null
AU - Bachtiar, Novilia Sjafri
AU - Sari, Rini Mulia
PY - 2017/6/1
Y1 - 2017/6/1
N2 - 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.
AB - 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.
KW - Infants, local reactions, Pentabio®, post marketing surveillance, systemic reactions
U2 - 10.15395/mkb.v49n2.1052
DO - 10.15395/mkb.v49n2.1052
M3 - Article
VL - 49
SP - 86
EP - 93
JO - Majalah Kedokteran Bandung (MKB) Bandung Medical Journal
JF - Majalah Kedokteran Bandung (MKB) Bandung Medical Journal
IS - 2
ER -
