Assessment of safety in newborns of mothers participating in clinical trials of vaccines administered during pregnancy

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.

Keywords: clinical trials; maternal immunization; safety; pregnancy; vaccines.

MeSH terms

  • Clinical Trials as Topic*
  • Female
  • Humans
  • Infant, Newborn
  • Mothers
  • Pregnancy
  • Pregnancy Complications, Infectious / prevention & control*
  • Pregnancy Outcome
  • United States
  • Vaccination
  • Vaccines / administration & dosage*
  • Vaccines / adverse effects*

Substances

  • Vaccines