Kaiser Permanente Vaccine Study Center, Oakland, CA, USA.
Pediatr Infect Dis J. 2010 Jul;29(7):613-7. doi: 10.1097/INF.0b013e3181d581f9.
Prelicensure clinical studies may not include sufficient numbers of subjects to assess the potential for rare postvaccination adverse events. The aim of this postlicensure study (NCT00297856) was to evaluate uncommon outcomes following vaccination with a tetanus, reduced-antigen-content diphtheria, and acellular pertussis vaccine (Tdap, Boostrix GlaxoSmithKline) in a large adolescent cohort.
We monitored safety outcomes among 13,427 10 to 18-year-old adolescents enrolled in the Northern California Kaiser Permanente Health Care Plan who received Tdap vaccination as part of their normal health care. Subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 postvaccination for neurologic events, hematologic events and allergic reactions. We evaluated new onset chronic illnesses within 6 months of Tdap vaccination by comparing with historical Td controls matched for age at vaccination, season, sex, and geographic area. We also compared the incidence of events of interest between the Tdap and historical cohorts as exploratory analyses.
No increased risk for medically attended neurologic (odds ratio [OR], 0.962; 95% confidence interval [CI], 0.533-1.733) or allergic reactions (OR, 1.091; 95% CI, 0.441-2.729) was observed following Tdap vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of Tdap, compared with 0 events within days 30 to 59 (P = 1.0). When compared with matched historical Td recipients, no increase in new onset chronic illnesses (OR, 0.634; 95% CI, 0.475-0.840) was seen after Tdap. No deaths occurred in the Tdap cohort during the study.
This study provides no evidence for an increased risk for neurologic, hematologic, allergic events, or new onset of chronic illnesses among adolescents vaccinated with Tdap.
上市前临床研究中纳入的研究对象数量可能不足，无法评估疫苗接种后的罕见不良事件。本研究（NCT00297856）旨在评价青少年人群接种破伤风、减量白喉和无细胞百日咳联合疫苗（Tdap，Boostrix GlaxoSmithKline）后的罕见不良结局。
我们对北加利福尼亚 Kaiser Permanente 医疗保健计划中 13427 名 1018 岁青少年接种 Tdap 疫苗后的安全性结局进行监测。通过自身对照分析，比较接种后 029 天与 30~59 天的神经事件、血液事件和过敏反应。通过与接种年龄、季节、性别和地理区域匹配的历史 Td 对照比较，评估接种 Tdap 后 6 个月内新发慢性疾病。我们还对 Tdap 队列和历史队列的感兴趣事件的发生率进行了比较，作为探索性分析。
与接种后前 30 天相比，接种 Tdap 后第 3059 天，在就诊的神经（比值比 [OR]，0.962；95%置信区间 [CI]，0.5331.733）或过敏反应（OR，1.091；95% CI，0.4412.729）风险未见增加。Tdap 后 30 天内发生 1 例血液事件，而 3059 天内无事件发生（P=1.0）。与匹配的历史 Td 接受者相比，接种 Tdap 后新发慢性疾病的发生率无增加（OR，0.634；95% CI，0.475~0.840）。研究期间，Tdap 组无死亡病例。
本研究未发现接种 Tdap 的青少年神经、血液、过敏事件或新发慢性疾病风险增加的证据。
