Department of Obstetrics and Gynecology, Division Maternal-Fetal Medicine, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.
Vaccine. 2013 Sep 13;31(40):4264-73. doi: 10.1016/j.vaccine.2013.07.031. Epub 2013 Jul 29.
The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss enrollment and safety assessments of pregnant women in clinical trials of vaccines. Experts in obstetrics, maternal-fetal medicine, infectious diseases, pediatrics, neonatology, genetics, vaccinology and clinical trial design were charged with identifying normal ranges for vital signs and laboratory assessments in pregnancy. A grading system for adverse events was then developed.
美国国立卫生研究院过敏与传染病研究所微生物学和传染病分部组织了一系列会议，题为“招募孕妇参加疫苗和疗法临床试验”，旨在讨论如何招募孕妇并对其在疫苗临床试验中的安全性进行评估。产科、母胎医学、传染病学、儿科学、新生儿学、遗传学、疫苗学和临床试验设计等领域的专家负责确定妊娠期间生命体征和实验室评估的正常值范围。然后制定了不良事件分级系统。
