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在先前破伤风疫苗接种后不到 2 年内接种破伤风-白喉-无细胞百日咳疫苗(Tdap)的安全性:在呼吸道疾病爆发期间进行的一次医疗保健人员大规模疫苗接种活动期间的经验。

The safety of immunizing with tetanus-diphtheria-acellular pertussis vaccine (Tdap) less than 2 years following previous tetanus vaccination: Experience during a mass vaccination campaign of healthcare personnel during a respiratory illness outbreak.

机构信息

Dartmouth Medical School, Hanover, NH, USA.

出版信息

Vaccine. 2010 Nov 23;28(50):8001-7. doi: 10.1016/j.vaccine.2010.09.034. Epub 2010 Sep 25.

Abstract

BACKGROUND

Tdap is recommended for health care personnel (HCP) aged <65 years who received tetanus diphtheria or tetanus toxoid immunization (Td/TT) ≥2 years earlier. During a medical center Tdap vaccination campaign, we assessed the safety of use of a Td/TT to Tdap interval <2 years in HCP. We also describe reactogenicity in HCP who were aged ≥65 years or pregnant.

METHODS

HCP vaccinated with Tdap were surveyed to assess time since last Td/TT (≥2 years vs. <2 years), age, pregnancy status, and injection site adverse events (AEs) during the 2 weeks after Tdap. AE rates were calculated and compared by non-inferiority analysis using a predetermined margin of 10%. We searched clinic logbooks to assess for clinically important adverse events during the 2 months after Tdap.

RESULTS

Of the 4524 vaccinated HCP, 2221 (49.1%) completed a safety survey which met criteria for analysis. Non-inferiority analysis found that rates of moderate and/or severe injection site AEs were not significantly greater in those vaccinated <2 years than in those vaccinated ≥2 years after previous Td/TT. Three serious adverse events were reported during the 2 months after vaccination, none in persons who were ≥65 years, pregnant or received Td/TT <2 years before.

CONCLUSIONS

Our findings add to the body of evidence that a short interval between Td/TT and a single dose of Tdap is safe.

摘要

背景

建议年龄<65 岁且既往接种过破伤风类毒素、白喉类毒素或破伤风-白喉联合疫苗(Td/TT)≥2 年的医护人员(HCP)接种 Tdap。在一次医疗中心 Tdap 疫苗接种活动中,我们评估了 HCP 中 Td/TT 至 Tdap 间隔<2 年的使用安全性。我们还描述了年龄≥65 岁或妊娠的 HCP 的不良反应发生率。

方法

接种 Tdap 的 HCP 接受调查,以评估上次接种 Td/TT 的时间(≥2 年与<2 年)、年龄、妊娠状态以及 Tdap 接种后 2 周内的注射部位不良反应(AE)。使用预先确定的 10%差值进行非劣效性分析,计算并比较 AE 发生率。我们查阅诊所日志,以评估 Tdap 接种后 2 个月内的临床重要不良事件。

结果

在 4524 名接种的 HCP 中,有 2221 名(49.1%)完成了符合分析标准的安全性调查。非劣效性分析发现,与上次接种 Td/TT≥2 年后接种者相比,接种 Td/TT<2 年后接种者中度和/或重度注射部位 AE 发生率并无显著增加。接种后 2 个月报告了 3 例严重不良事件,≥65 岁、妊娠或 Td/TT<2 年前接种者均无此类事件。

结论

我们的研究结果进一步证明了 Td/TT 与 Tdap 单剂接种间隔较短是安全的。

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