TY - JOUR
T1 - Research on vaccines during pregnancy
T2 - Reference values for vital signs and laboratory assessments
AU - Sheffield, Jeanne S.
AU - Munoz, Flor M.
AU - Beigi, Richard H.
AU - Rasmussen, Sonja A.
AU - Edwards, Kathryn M.
AU - Read, Jennifer S.
AU - Heine, R. Phillips
AU - Ault, Kevin A.
AU - Swamy, Geeta K.
AU - Jevaji, Indira
AU - Spong, Catherine Y.
AU - Fortner, Kimberly B.
AU - Patel, Shital M.
AU - Nesin, Mirjana
PY - 2013/9/13
Y1 - 2013/9/13
N2 - 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.
AB - 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.
KW - Laboratory assessment
KW - Maternal immunization
KW - Toxicity grading scale
UR - http://www.scopus.com/inward/record.url?scp=84882882133&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84882882133&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2013.07.031
DO - 10.1016/j.vaccine.2013.07.031
M3 - Article
C2 - 23906887
AN - SCOPUS:84882882133
SN - 0264-410X
VL - 31
SP - 4264
EP - 4273
JO - Vaccine
JF - Vaccine
IS - 40
ER -