Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America
Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America
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DOI：
10.1016/j.cmi.2018.01.018
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发表时间：
2018-07-01
影响因子：
14.2
通讯作者：
Zambrano, B.
中科院分区：
文献类型：
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作者：
Arredondo-Garcia, J. L.;Hadinegoro, S. R.;Zambrano, B.
目的：我们的目的是在比较四价登革热疫苗与安慰剂的三项随机临床试验中，描述病毒学确诊的登革热 (VCD) 入院风险以及首次接种后长达 4 年（第 1 至第 4 年）发生临床严重住院 VCD 的风险。方法：在单独研究和组合研究中按年份和年龄组估计了从首次接种到第 4 年住院 VCD 的相对风险 (RR)。 结果：总体而言，从第 1 年到第 2 年4、疫苗接种组 (n = 22 603) 和安慰剂组 (n = 11 301) 分别有 233 名和 228 名参与者至少发生过一次住院 VCD（RR = 0.511，95% CI 0.42 -0.62）。其中，临床重症病例分别为 48 例和 47 例。在 9 岁以上的儿童中，疫苗接种组 (n = 17 629) 和安慰剂组 (n = 8821) 分别有 88 名和 136 名参与者至少发生过一次住院 VCD（RR = 0.324；95% CI 0.24-0.43）。在年龄已接种疫苗的参与者中
Objective: Our objective was to describe the risk of hospital admission for virologically confirmed dengue (VCD) and the risk of clinically severe hospitalized VCD occurring up to 4 years after the first dose (years 1 to 4) in three randomized clinical trials comparing tetravalent dengue vaccine with placebo.Methods: The relative risks (RR) for hospitalized VCD from first dose to year 4 were estimated by year and age-group in individual and combined studies.Results: Overall, from Year 1 to Year 4, 233 and 228 participants had at least one episode of hospitalized VCD in the vaccinated (n = 22 603) and placebo (n = 11 301) groups, respectively (RR = 0.511, 95% CI 0.42 -0.62). Among these, 48 and 47 cases, respectively, were classified as clinically severe. In children aged >= 9 years, 88 and 136 participants had at least one episode of hospitalized VCD in the vaccinated (n = 17 629) and placebo (n = 8821) groups, respectively (RR = 0.324; 95% CI 0.24-0.43). In vaccinated participants aged