Research on vaccines during pregnancy: reference values for vital signs and laboratory assessments.

Sheffield JS, Munoz FM, Beigi RH, Rasmussen SA, Edwards KM, Read JS, Heine RP, Ault KA, Swamy GK, Jevaji I, Spong CY, Fortner KB, Patel SM, Nesin M
Vaccine. 2013 31 (40): 4264-73

PMID: 23906887 · DOI:10.1016/j.vaccine.2013.07.031

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.

Copyright © 2013 Elsevier Ltd. All rights reserved.

MeSH Terms (10)

Blood Chemical Analysis Female Humans Infant, Newborn Infant, Newborn, Diseases Pregnancy Pregnancy Complications, Infectious Reference Values Vaccination Vaccines

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