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对参与孕期疫苗临床试验的母亲所生新生儿的安全性评估。

Assessment of safety in newborns of mothers participating in clinical trials of vaccines administered during pregnancy.

作者信息

Munoz Flor M, Weisman Leonard E, Read Jennifer S, Siberry George, Kotloff Karen, Friedman Jennifer, Higgins Rosemary D, Hill Heather, Seifert Harry, Nesin Mirjana

机构信息

Department of Pediatrics Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas.

Department of Pediatrics.

出版信息

Clin Infect Dis. 2014 Dec 15;59 Suppl 7(Suppl 7):S415-27. doi: 10.1093/cid/ciu727.

DOI:10.1093/cid/ciu727
PMID:25425720
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4303057/
Abstract

A panel of experts convened by the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, developed proposed guidelines for the evaluation of adverse events in newborns of women participating in clinical trials of maternal immunization in the United States.

摘要

美国国立卫生研究院国家过敏和传染病研究所微生物学与传染病司召集了一个专家小组,制定了关于评估参与美国孕产妇免疫临床试验的妇女所生新生儿不良事件的拟议指南。

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本文引用的文献

1
Assessment of congenital anomalies in infants born to pregnant women enrolled in clinical trials.对参与临床试验的孕妇所生婴儿先天性异常的评估。
Clin Infect Dis. 2014 Dec 15;59 Suppl 7(Suppl 7):S428-36. doi: 10.1093/cid/ciu738.
2
Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial.孕妇接种破伤风白喉无细胞百日咳(Tdap)疫苗的安全性和免疫原性:一项随机临床试验。
JAMA. 2014 May 7;311(17):1760-9. doi: 10.1001/jama.2014.3633.
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Research on vaccines during pregnancy: protocol design and assessment of safety.妊娠期疫苗研究:方案设计与安全性评估。
Vaccine. 2013 Sep 13;31(40):4274-9. doi: 10.1016/j.vaccine.2013.07.042. Epub 2013 Jul 29.
4
Research on vaccines during pregnancy: reference values for vital signs and laboratory assessments.妊娠期疫苗研究:生命体征和实验室评估参考值。
Vaccine. 2013 Sep 13;31(40):4264-73. doi: 10.1016/j.vaccine.2013.07.031. Epub 2013 Jul 29.
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Preventing newborn infection with maternal immunization.通过母体免疫预防新生儿感染。
Sci Transl Med. 2013 Jul 24;5(195):195ps11. doi: 10.1126/scitranslmed.3005451.
6
ACOG Committee Opinion No. 566: Update on immunization and pregnancy: tetanus, diphtheria, and pertussis vaccination.美国妇产科医师学会委员会意见 No.566:免疫接种和妊娠更新:破伤风、白喉和百日咳疫苗接种。
Obstet Gynecol. 2013 Jun;121(6):1411-1414. doi: 10.1097/01.AOG.0000431054.33593.e3.
7
Immune responses in infants whose mothers received Tdap vaccine during pregnancy.孕妇在孕期接种 Tdap 疫苗对婴儿的免疫应答。
Pediatr Infect Dis J. 2013 Nov;32(11):1257-60. doi: 10.1097/INF.0b013e3182a09b6a.
8
Maternal immunization as a strategy to decrease susceptibility to infection in newborn infants.母体免疫接种作为降低新生儿感染易感性的策略。
Curr Opin Infect Dis. 2013 Jun;26(3):248-53. doi: 10.1097/QCO.0b013e3283607a58.
9
Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women--Advisory Committee on Immunization Practices (ACIP), 2012.更新的孕妇破伤风类毒素、白喉类毒素和无细胞百日咳疫苗(Tdap)使用建议——免疫实践咨询委员会(ACIP),2012 年。
MMWR Morb Mortal Wkly Rep. 2013 Feb 22;62(7):131-5.
10
Priorities for research on meningococcal disease and the impact of serogroup A vaccination in the African meningitis belt.脑膜炎球菌病研究重点及 A 群脑膜炎球菌疫苗接种对非洲脑膜炎地带的影响。
Vaccine. 2013 Mar 1;31(11):1453-7. doi: 10.1016/j.vaccine.2012.12.035. Epub 2012 Dec 27.