Immunogenicity and safety of diphtheria–tetanus vaccine in pre-adolescent and adolescent South Koreans

Lee, Soo Young; Kwak, Ga Young; Nam, Chan Hee; Kim, Jong Hyun; Hur, Jae Kun; Lee, Kyung-Yil; Park, Joon Su; Kim, Hwang Min; Kang, Jin Han

doi:10.1016/j.vaccine.2009.03.037

Cited by 11 publications

(17 citation statements)

References 12 publications

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“…In the present study, the most common systemic AE was malaise rather than headache. Malaise as the most common systemic AE was similar to the results of a previous study in Korea, 24 suggesting that malaise might be a race-specific AE. The rates of systemic AEs of the two groups were not significantly different.…”

Section: Discussionsupporting

confidence: 87%

Immunogenicity and safety of the new reduced-dose tetanus–diphtheria vaccine in healthy Korean adolescents: A comparative active control, double-blind, randomized, multicenter phase III study

Han

Rhim

Shin

et al. 2017

Journal of Microbiology, Immunology and Infection

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Section: Discussionsupporting

confidence: 87%

Immunogenicity and safety of the new reduced-dose tetanus–diphtheria vaccine in healthy Korean adolescents: A comparative active control, double-blind, randomized, multicenter phase III study

Han

Rhim

Shin

et al. 2017

Journal of Microbiology, Immunology and Infection

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“…More local (68-83%) and systemic (25-32%) adverse events were reported in that study. This discrepancy might be due to active reporting of adverse events by parents in that study (13, 14). A study performed by Khetsuriani et al (19) reported only a 5.3% adverse reaction rate from 248 participants.…”

Section: Discussionmentioning

confidence: 74%

“…The vaccination rate is now approximately 40% in 11-12 yr old (7). The effectiveness and safety of booster injection of Td vaccine in pre-adolescent and adolescent were reported in Korea (13, 14). But this vaccine is rarely done in adults, except for tetanus prophylaxis in cases of traumatic injuries.…”

Section: Introductionmentioning

confidence: 99%

Immunogenicity and Safety of Diphtheria-tetanus Vaccine in Adults

et al. 2010

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This study was conducted to evaluate the immunogenicity and safety of diphtheria-tetanus (Td) vaccine in adults over 40 yr old who had never received a diphtheria-tetanus-pertussis (DTP) vaccination. A total of 242 subject completed three-doses of Td vaccination and subsequent assays for immunogenicity. Before vaccination, 33.9% and 96.7% participants showed antibody levels of diphtheria and tetanus, respectively, which were below protective level (<0.1 U/mL). After the first dose of Td vaccine, 92.6% and 77.6% of subjects gained protective antibody concentrations (≥0.1 U/mL) for diphtheria and tetanus, with an increase to 99.6% and 100% after the third dose. Local and systemic adverse events occurred in 37.9% and 15.5% of the subjects. No serious adverse event requiring an unscheduled hospital visit occurred. In conclusion, three-doses of Td vaccination to unimmunized adults are safe and effective in inducing protective immunity against diphtheria and tetanus.

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“…Hal ini terlihat pada studi vaksin Td di Korea Selatan dengan membandingkan reaksi yang timbul pada anak praremaja dengan remaja, terlihat anak praremaja secara bermakna mengalami reaksi yang lebih banyak ditemukan pada kelompok usia lebih muda (praremaja) (p=0,006). 12 Angka kejadian kemerahan pada tempat bekas suntikan tertinggi pada hari ke-1 pascaimunisasi sebesar 13,09%, dengan intensitas umumnya adalah ringan. Keadaan ini tidak jauh berbeda dari studi sebelumnya bahwa kemerahan ditemukan pada 14,2%, 10 namun pada studi vaksin Td yang lainnya pada orang dewasa ternyata didapatkan lebih tinggi, yaitu 50%.…”

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“…Angka seroproteksi ini mirip bila dibandingkan dengan studi lainnya di India dan Korea, 96-100% anak mempunyai titer protektif baik terhadap difteria maupun tetanus. 12,13 Sebanyak 20,13% anak belum dapat terlindungi terhadap difteria praimunisasi. Keadaan ini tentu saja menyebabkan anak tersebut berisiko untuk tertulari penyakit difteria karena berdomisili di daerah dengan KLB (kejadian luar biasa) difteria.…”

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

Sundoro¹,

Bachtıar²,

Syafriyal³

et al. 2014

mkb

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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. [...

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Immunogenicity and safety of diphtheria–tetanus vaccine in pre-adolescent and adolescent South Koreans

Cited by 11 publications

References 12 publications

Immunogenicity and safety of the new reduced-dose tetanus–diphtheria vaccine in healthy Korean adolescents: A comparative active control, double-blind, randomized, multicenter phase III study

Immunogenicity and safety of the new reduced-dose tetanus–diphtheria vaccine in healthy Korean adolescents: A comparative active control, double-blind, randomized, multicenter phase III study

Immunogenicity and Safety of Diphtheria-tetanus Vaccine in Adults

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

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