https://scholars.lib.ntu.edu.tw/handle/123456789/548822
標題: | Assessment of pre-specified adverse events following varicella vaccine: A population-based self-controlled risk interval study | 作者: | Liu C.-H. Yeh Y.-C. Wan-Ting Huang WEI-CHU CHIE KIN-WEI CHAN |
公開日期: | 2020 | 出版社: | Elsevier Ltd | 卷: | 38 | 期: | 11 | 起(迄)頁: | 2495-2502 | 來源出版物: | Vaccine | 摘要: | Background: Clinical trials and spontaneous reporting systems have revealed rare but biologically plausible adverse events following varicella immunization. Few post-marketing controlled studies have been conducted to assess the relationship between the varicella vaccine and these outcomes. Objectives: To evaluate the risk of pneumonia, idiopathic thrombocytopenic purpura (ITP), meningitis, encephalitis and ischemic stroke following varicella immunization. Materials and methods: This nationwide observational study was based on Taiwan National Health Insurance data and National Immunization Information System from 2004 through 2014. Primary analysis included children aged 12–35 months who received the single varicella vaccine on the date of administration. The self-controlled risk interval design compared the incidence of pre-specified outcomes during a risk interval of 1–42 days post-vaccination and a control interval of 43–84 days. The outcomes of interest were defined as admitted pneumonia, ITP, meningitis, encephalitis, and ischemic stroke, as well as fracture as a negative control. Conditional Poisson regression was used to assess the incidence rate ratio (aIRR) with adjustments for age and seasonal effects. Results: Among 1,194,189 children, who receiving the varicella vaccine, there was no observed increase in the risk for ITP (aIRR 1.00; 95% CI, 0.76–1.33), meningitis (aIRR 1.21; 95% CI, 0.49–2.95), encephalitis (aIRR 1.00; 95% CI, 0.62–1.60), or ischemic stroke (aIRR 1.24; 95% CI, 0.31–4.95). A clustering feature with pneumonia occurred during days 36–42 post-vaccination (aIRR 1.10; 95% CI, 1.02–1.18). An increase in the risk for ITP was observed in children receiving the varicella and MMR vaccines concomitantly (aIRR 1.70; 95% CI, 1.19–2.43), but not among those receiving the varicella vaccine only. Conclusions: We detected a small risk of incidental pneumonia associated with varicella vaccine in the 6th week after immunization. There was no increase in the risk of other pre-specified adverse events. ? 2020 Elsevier Ltd |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85079194892&doi=10.1016%2fj.vaccine.2020.01.090&partnerID=40&md5=2347f54080b10bb51beae63729c98225 https://scholars.lib.ntu.edu.tw/handle/123456789/548822 |
ISSN: | 0264-410X | DOI: | 10.1016/j.vaccine.2020.01.090 | SDG/關鍵字: | chickenpox vaccine; measles mumps rubella vaccine; chickenpox vaccine; live vaccine; measles mumps rubella vaccine; Article; brain ischemia; chickenpox; child; cohort analysis; controlled study; drug safety; encephalitis; female; fracture; hospital admission; hospitalization; human; ICD-9-CM; idiopathic thrombocytopenic purpura; incidence; major clinical study; male; observational study; pneumonia; population research; preschool child; priority journal; risk factor; self concept; self controlled risk interval; treatment outcome; vaccination; chickenpox; epidemiology; infant; Taiwan; Chickenpox; Chickenpox Vaccine; Child, Preschool; Humans; Infant; Measles-Mumps-Rubella Vaccine; Taiwan; Vaccines, Attenuated |
顯示於: | 腫瘤醫學研究所 |
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