title: Assessment of safety in newborns of mothers participating in clinical trials of vaccines administered during pregnancy.
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.
authors.affiliation: Department of Pediatrics Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas.
authors.forename: Flor M
authors.initials: FM
authors.lastname: Munoz
authors.affiliation: Department of Pediatrics.
authors.forename: Leonard E
authors.initials: LE
authors.lastname: Weisman
authors.affiliation: Division of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Read
authors.affiliation: Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
authors.forename: George
authors.initials: G
authors.lastname: Siberry
authors.affiliation: Department of Pediatrics, University of Maryland, Baltimore.
authors.forename: Karen
authors.initials: K
authors.lastname: Kotloff
authors.affiliation: Center for International Health Research, Rhode Island Hospital and Department of Pediatrics, Alpert Medical School of Brown University, Providence.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Friedman
authors.affiliation: Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda.
authors.forename: Rosemary D
authors.initials: RD
authors.lastname: Higgins
authors.affiliation: The EMMES Corporation, Rockville, Maryland.
authors.forename: Heather
authors.initials: H
authors.lastname: Hill
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Harry
authors.initials: H
authors.lastname: Seifert
authors.affiliation: Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
authors.forename: Mirjana
authors.initials: M
authors.lastname: Nesin
mesh_terms: D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D009035:Mothers; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control*; D011256:Pregnancy Outcome; D014481:United States; D014611:Vaccination; D014612:Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D014612:Vaccines
keywords: clinical trials; maternal immunization; safety; pregnancy; vaccines