Assessment of safety in newborns of mothers participating in clinical trials of vaccines administered during pregnancy.
2014 Dec 15
Journal Article
Authors:
Munoz, F.M.;
Weisman, L.E.;
Read, J.S.;
Siberry, G.;
Kotloff, K.;
Friedman, J.;
Higgins, R.D.;
Hill, H.;
Seifert, H.;
Nesin, M.
Secondary:
Clin Infect Dis
Volume:
59 Suppl 7
Pagination:
S415-27
PMID:
25425720
Keywords:
Clinical Trials as Topic; Female; Humans; Infant, Newborn; Mothers; Pregnancy; Pregnancy Complications, Infectious; Pregnancy Outcome; United States; Vaccination; Vaccines
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.