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

Jeanne S. Sheffield, Flor M. Munoz, Richard H. Beigi, Sonja A. Rasmussen, Kathryn M. Edwards, Jennifer S. Read, R. Phillips Heine, Kevin A. Ault, Geeta K. Swamy, Indira Jevaji, Catherine Y. Spong, Kimberly B. Fortner, Shital M. Patel, Mirjana Nesin

Research output: Contribution to journalArticlepeer-review

16 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)4264-4273
Number of pages10
JournalVaccine
Volume31
Issue number40
DOIs
StatePublished - Sep 13 2013

Keywords

  • Laboratory assessment
  • Maternal immunization
  • Toxicity grading scale

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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