title: Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.
abstract: Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries.
authors.affiliation: Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's, University of London, UK.
authors.forename: Christine E
authors.initials: CE
authors.lastname: Jones
authors.affiliation: Baylor College of Medicine, Houston, TX, United States.
authors.forename: Flor M
authors.initials: FM
authors.lastname: Munoz
authors.affiliation: Henry Jackson Foundation, Bethesda, MD, United States.
authors.forename: Hans M L
authors.initials: HM
authors.lastname: Spiegel
authors.affiliation: University of Basel Children's Hospital, Basel, Switzerland.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Heininger
authors.affiliation: 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.
authors.forename: Patrick L F
authors.initials: PL
authors.lastname: Zuber
authors.affiliation: Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University, Nashville, TN, United States.
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Edwards
authors.affiliation: Initiative for Vaccine Research, World Health Organization, Geneva, Switzerland.
authors.forename: Philipp
authors.initials: P
authors.lastname: Lambach
authors.affiliation: International Alliance of Biological Standardization, IABS-EU, Lyon, France.
authors.forename: Pieter
authors.initials: P
authors.lastname: Neels
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Katrin S
authors.initials: KS
authors.lastname: Kohl
authors.affiliation: Global Immunization Division, Center for Global Health, CDC, Atlanta, GA, United States.
authors.forename: Jane
authors.initials: J
authors.lastname: Gidudu
authors.affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States.
authors.forename: Steven
authors.initials: S
authors.lastname: Hirschfeld
authors.affiliation: Division of Pediatrics Allergy, Immunology & Infectious Diseases, Rutgers, New Jersey Medical School, Newark, NJ, United States.
authors.forename: James M
authors.initials: JM
authors.lastname: Oleske
authors.affiliation: Infectious Disease and Vaccine Center, University of Jordan, Amman, Jordan.
authors.forename: Najwa
authors.initials: N
authors.lastname: Khuri-Bulos
authors.affiliation: Brighton Collaboration Foundation, Switzerland.
authors.forename: Jorgen
authors.initials: J
authors.lastname: Bauwens
authors.affiliation: University of Washington, Seattle, WA, United States.
authors.forename: Linda O
authors.initials: LO
authors.lastname: Eckert
authors.affiliation: Global Healthcare Consulting, India.
authors.forename: Sonali
authors.initials: S
authors.lastname: Kochhar
authors.affiliation: University of Basel Children's Hospital, Basel, Switzerland.
authors.forename: Jan
authors.initials: J
authors.lastname: Bonhoeffer
authors.affiliation: Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's, University of London, UK. Electronic address: contact@brightoncollaboration.org.
authors.forename: Paul T
authors.initials: PT
authors.lastname: Heath
mesh_terms: D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007223:Infant; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control; D013223:Statistics as Topic; D014611:Vaccination / Q000009:adverse effects*; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D014612:Vaccines
keywords: Adverse event; Clinical trials; Guidelines; Immunization; Pregnancy; Safety; Vaccines