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BACKGROUND The Indonesian Expanded Program of Immunization has implemented tetanus and diphtheria (Td) vaccination to replace the tetanus toxoid vaccine in pregnant women since the year 2016. Td vaccine is administered to protect against diphtheria and tetanus to the mother and her baby as well. This prospective study was conducted to assess the adverse reactions after Td immunization; besides, a retrospective study was conducted to observe the presence of severe local reaction (Arthus reaction), premature birth, and low birth weight history in the medical records of pregnant women who had received Td immunization in the past year.METHODS A prospective observational study was conducted in 200 pregnant women. Local reactions and systemic events occurring within 28 days after immunization were recorded in the diary card and were confirmed by the health worker in the follow-up visit. A retrospective study was also conducted to evaluate 750 medical records of pregnant women who had received Td immunization. The study was conducted from September 2017 to January 2018. The study has been registered at ClinicalTrials.gov ID: NCT03383653. RESULTSIn 185 pregnant women who completed the study, the most common local reaction was pain, occurring in 33.5% of subjects within 24 hours after vaccination. Fever, other systemic reactions, and serious adverse events were not reported during the observation. In the retrospective study, 647 medical records were validated. No Arthus reaction was observed. The prevalence of premature birth was 1.24%, and that of low birth weight was 2.63%, which were below the normal rates.CONCLUSIONS Td vaccination in pregnant women was safe and well-tolerated.

BACKGROUND In 2017, the Indonesian Technical Advisory Group on Immunization recommended a safety monitoring demonstration program for the 13-valent pneumococcal conjugate vaccine (PCV13) in West Lombok and East Lombok, West Nusa Tenggara to evaluate the 2-dose primary series (2 and 3 months of age) for serious adverse events (SAEs), adverse events, systemic events, and local reactions. METHODS A total of 1,083 infants from 10 primary healthcare centers were analyzed, with 687 receiving the first dose and 396 receiving the second dose. Based on the national immunization program, they received PCV13 + DTwP-HB-Hib + OPV (n = 544), PCV13 + DTwP-HB-Hib (n = 101), or PCV13 only (n = 403). They were monitored for 30 min after vaccination for any immediate SAEs, and parents were given a diary card to record safety information prospectively for 28 days. RESULTS No immediate SAEs were observed, and no SAEs were reported during 28 days after vaccination. Reports of local reactions and systemic events predominated on days 1–3 post-vaccination. Severe fever (axillary temperature >39.0°C) was uncommon (<2% of all infants). Most irritability was mild to moderate. Local pain was more frequent after the first dose than after the second dose. It was distributed evenly across mild, moderate, and severe classifications, while redness and swelling were mostly mild to moderate. CONCLUSIONS The PCV13 primary series demonstration program in Indonesia confirmed tolerable local and systemic reactions.

AbstrakVaksin Td diberikan untuk melindungi populasi usia 7 tahun atau lebih dari penyakit tetanus dan difteria. Tujuan penelitian ini adalah untuk mengetahui reaksi dan respons imun setelah memperoleh 1 dosis vaksin Td. Penelitian ini merupakan post marketing surveillance, dengan desain kohort pada anak sekolah dasar di Jawa Timur. Reaksi lokal dan sistemik dicatat pada kartu harian hingga 28 hari setelah imunisasi. Darah diambil sebelum dan 28 hari setelah imunisasi. Pengukuran antibodi menggunakan metode uji double antigen ELISA, dengan batas proteksi 0,01 IU/mL baik untuk antitetanus maupun antidifteria. Pengamatan yang berlangsung dari Oktober 2010 hingga April 2011 ini melibatkan sebanyak 2.978 anak sekolah dasar, termasuk 159 anak untuk kelompok respons imun. Sebanyak 1,18-2,45% anak mengalami demam dengan instensitas mayoritas ringan. Reaksi lokal terbanyak adalah nyeri pada 30 menit setelah imunisasi 62,49% naik menjadi 83,38% pada hari ke-1, dan menurun pada hari berikutnya dengan intensitas mayoritas adalah ringan. Tidak ditemukan kejadian pascaimunisasi serius. Sebanyak 98,11% dan 99,37% anak terlindungi terhadap difteria dan tetanus dengan geometric mean titer 1,2280 IU/mL (p=0,000) untuk antidifteria dan 10,6068 IU/mL (p=0,009) untuk antitetanus. Simpulan, dari hasil pengamatan menunjukkan bahwa vaksin ini bersifat imunogenik dan aman setelah pemberian 1 (satu) dosis pada anak sekolah dasar. [MKB. 2014;46(3) Protectivity, Local Reaction, and Systemic Reaction Following Td Vaccination among Elementary School Students in Indonesia AbstractTd vaccine is given to provide protection to tetanus and diphtheria in children 7 years old or above. The objective of this study was to evaluate the reactions and immune response after 1 dose of Td vaccine. This study was 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 a cut off protection rate >0.01 IU/ml. Observation were performed between October 2010 and April 2011 which involved 2,978 elementary school students, including 159 subjects for the immune response group. In this study, fever occured in 1.18-2.45% subjects at the first three days with mild intensity and it resolved immediately without any medication. The most frequently found local reaction was pain in 62.49% subjects at 30 minutes after injection and increased to 83.38% at day 1 after immunization. The pain decreased the day after, with mostly mild intensity. No serious adverse reaction was found. It was found that 98.11% and 99.37% subjects were protected from diphtheria and tetanus with a Geometric Mean Titer of 12280 IU/mL (p=0.000) for anti diphtheria and 10.6068 IU/mL (p=0.009) for anti tetanus. Therefore, it is concluded that Td vaccine is safe and immunogenic after one dose in school age children without any serious adverse event. [...