title: Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy.
abstract: Vaccination in pregnancy is an effective strategy to prevent serious infections in mothers and their infants. Safety of this strategy is of principal importance to all stakeholders. As the number of studies assessing safety of vaccines in pregnancy increases, the need to ensure consistent collection and reporting of critical data to allow comparisons and data pooling becomes more important. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project aims to improve data collection and create a shared understanding of maternal, fetal and neonatal outcomes in order to progress the global agenda for vaccination in pregnancy. The guidance in this document has been developed to harmonize the data collected in case report forms used for safety monitoring in clinical trials of vaccination in pregnant women. Data to be collected is prioritized to allow applicability in diverse research settings, including low and middle-income countries. Standardized data will enable the research community to have a common base upon which to conduct meta-analyses, strengthening the applicability of outcomes to different settings.
authors: Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London, UK. Electronic address: contact@brightoncollaboration.org.
authors: Christine E
authors: CE
authors: Jones
authors: Baylor College of Medicine, Houston, TX, USA.
authors: Flor M
authors: FM
authors: Munoz
authors: Global Healthcare Consulting, India.
authors: Sonali
authors: S
authors: Kochhar
authors: Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London, UK; School of Clinical Sciences, University of Bristol, UK.
authors: Stefania
authors: S
authors: Vergnano
authors: Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, South Africa; Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, South Africa.
authors: Clare L
authors: CL
authors: Cutland
authors: Cincinnati Children's Hospital Medical Center, USA.
authors: Mark
authors: M
authors: Steinhoff
authors: Center for Global Health, Cincinnati Children's Hospital, USA.
authors: Steven
authors: S
authors: Black
authors: University of Basel Children's Hospital, Basel, Switzerland.
authors: Ulrich
authors: U
authors: Heininger
authors: University of Basel Children's Hospital, Basel, Switzerland.
authors: Jan
authors: J
authors: Bonhoeffer
authors: Paediatric Infectious Diseases Research Group, Institute of Infection and Immunity, St George's, University of London, UK.
authors: Paul T
authors: PT
authors: Heath
mesh_terms: D002986:Clinical Trials as Topic; D003625:Data Collection; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D014943:Global Health; D006801:Humans; D007223:Infant; D011203:Poverty; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control; D011996:Records; D013223:Statistics as Topic; D014611:Vaccination / Q000009:adverse effects*; D014612:Vaccines / Q000009:adverse effects*
chemical_list: D014612:Vaccines
keywords: Adverse event; Case report form; Clinical trials; Guidance; Immunization; Pregnancy; Safety; Vaccines