Walls Tony, Graham Patricia, Petousis-Harris Helen, Hill Linda, Austin Nicola
Department of Paediatrics, University of Otago, Christchurch, New Zealand.
Department of Paediatrics, University of Otago, Christchurch, New Zealand Canterbury District Health Board, Christchurch, New Zealand.
BMJ Open. 2016 Jan 6;6(1):e009536. doi: 10.1136/bmjopen-2015-009536.
Pertussis vaccination during pregnancy has recently been recommended in both the USA and UK to prevent pertussis infection in infants. While there are no apparent safety concerns about the administration of Tdap vaccine during pregnancy, there is only limited safety data available. We aimed to closely monitor infants exposed to Tdap during pregnancy to look for any adverse outcomes that may be attributable to the vaccine.
This was a prospective observational study, collecting information to evaluate the safety of Tdap vaccine for infants exposed during pregnancy. Infants were followed for between 6 and 12 months after birth, with 84% completing 12 months of follow-up. Information was obtained from objective sources including routine health visits and vaccination records wherever possible, as well as frequent parental reports.
The Canterbury region of New Zealand.
A cohort of 403 infants whose mothers had received Tdap vaccine.
Gestational age at birth, growth parameters, congenital anomalies, immunisation status and timeliness of immunisation, development of pertussis infection.
There were no significant differences in birth weight, gestational age at birth, congenital anomalies or infant growth as compared with baseline population data. Infants of mothers who had received the vaccine were more likely to receive their vaccinations on time during infancy. No cases of pertussis occurred in this cohort despite high rates of disease in the community. We have not found any adverse events attributable to vaccine exposure.
These data add to the growing pool of evidence that the administration of Tdap vaccine during pregnancy is an appropriate strategy for reducing the burden of pertussis in infants.
Australia New Zealand Clinical Trials Registry ACTRN12613001045707.
美国和英国最近均建议在孕期接种百日咳疫苗，以预防婴儿百日咳感染。虽然孕期接种破伤风类毒素、白喉类毒素和无细胞百日咳疫苗（Tdap）并无明显安全问题，但可用的安全数据有限。我们旨在密切监测孕期接触Tdap疫苗的婴儿，以寻找可能归因于该疫苗的任何不良后果。
这是一项前瞻性观察性研究，收集信息以评估孕期接触Tdap疫苗对婴儿的安全性。婴儿在出生后6至12个月接受随访，84%的婴儿完成了12个月的随访。尽可能从客观来源获取信息，包括常规健康检查和疫苗接种记录，以及家长的频繁报告。
新西兰坎特伯雷地区。
一组403名母亲接种了Tdap疫苗的婴儿。
出生时的孕周、生长参数、先天性异常、免疫状况和免疫及时性、百日咳感染的发生情况。
与基线人群数据相比，出生体重、出生时的孕周、先天性异常或婴儿生长情况无显著差异。母亲接种过疫苗的婴儿在婴儿期更有可能按时接种疫苗。尽管社区百日咳发病率很高，但该队列中未发生百日咳病例。我们未发现任何可归因于疫苗接触的不良事件。
这些数据进一步证明，孕期接种Tdap疫苗是减轻婴儿百日咳负担的一项合适策略。
澳大利亚新西兰临床试验注册中心ACTRN12613001045707。
