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Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.
Jones, Christine E; Munoz, Flor M; Spiegel, Hans M L; Heininger, Ulrich; Zuber, Patrick L F; Edwards, Kathryn M; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T.
Affiliation
  • Jones CE; Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's, University of London, UK.
  • Munoz FM; Baylor College of Medicine, Houston, TX, United States.
  • Spiegel HM; Henry Jackson Foundation, Bethesda, MD, United States.
  • Heininger U; University of Basel Children's Hospital, Basel, Switzerland.
  • Zuber PL; Safety and Vigilance (SAV), Regulation of Medicines and other Health Technologies (RHT), Department of Essential Medicines and Health Products (EMP), Health Systems and Innovation (HIS), World Health Organization, Geneva, Switzerland.
  • Edwards KM; Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University, Nashville, TN, United States.
  • Lambach P; Initiative for Vaccine Research, World Health Organization, Geneva, Switzerland.
  • Neels P; International Alliance of Biological Standardization, IABS-EU, Lyon, France.
  • Kohl KS; Centers for Disease Control and Prevention, Atlanta, GA, United States.
  • Gidudu J; Global Immunization Division, Center for Global Health, CDC, Atlanta, GA, United States.
  • Hirschfeld S; Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States.
  • Oleske JM; Division of Pediatrics Allergy, Immunology & Infectious Diseases, Rutgers, New Jersey Medical School, Newark, NJ, United States.
  • Khuri-Bulos N; Infectious Disease and Vaccine Center, University of Jordan, Amman, Jordan.
  • Bauwens J; Brighton Collaboration Foundation, Switzerland.
  • Eckert LO; University of Washington, Seattle, WA, United States.
  • Kochhar S; Global Healthcare Consulting, India.
  • Bonhoeffer J; University of Basel Children's Hospital, Basel, Switzerland.
  • Heath PT; Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's, University of London, UK. Electronic address: contact@brightoncollaboration.org.
Vaccine ; 34(49): 5998-6006, 2016 12 01.
Article in En | MEDLINE | ID: mdl-27481360

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pregnancy / Vaccines / Clinical Trials as Topic / Vaccination Type of study: Guideline Limits: Female / Humans / Infant Language: En Journal: Vaccine Year: 2016 Document type: Article Affiliation country: United kingdom Country of publication: Netherlands

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pregnancy / Vaccines / Clinical Trials as Topic / Vaccination Type of study: Guideline Limits: Female / Humans / Infant Language: En Journal: Vaccine Year: 2016 Document type: Article Affiliation country: United kingdom Country of publication: Netherlands