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.
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
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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.
JAMA. 2014 May 7;311(17):1760-9. doi: 10.1001/jama.2014.3633.
3
Research on vaccines during pregnancy: protocol design and assessment of safety.
Vaccine. 2013 Sep 13;31(40):4274-9. doi: 10.1016/j.vaccine.2013.07.042. Epub 2013 Jul 29.
4
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Vaccine. 2013 Sep 13;31(40):4264-73. doi: 10.1016/j.vaccine.2013.07.031. Epub 2013 Jul 29.
5
Preventing newborn infection with maternal immunization.
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.
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.
Pediatr Infect Dis J. 2013 Nov;32(11):1257-60. doi: 10.1097/INF.0b013e3182a09b6a.
8
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Curr Opin Infect Dis. 2013 Jun;26(3):248-53. doi: 10.1097/QCO.0b013e3283607a58.
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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.
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