title: Neonatal death: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.
abstract: More than 40% of all deaths in children under 5 years of age occur during the neonatal period: the first month of life. Immunization of pregnant women has proven beneficial to both mother and infant by decreasing morbidity and mortality. With an increasing number of immunization trials being conducted in pregnant women, as well as roll-out of recommended vaccines to pregnant women, there is a need to clarify details of a neonatal death. This manuscript defines levels of certainty of a neonatal death, related to the viability of the neonate, who confirmed the death, and the timing of the death during the neonatal period and in relation to immunization of the mother.
authors.affiliation: Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa; Department of Science and Technology, National Research Foundation, Vaccine Preventable Diseases, South Africa; Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Jayani
authors.initials: J
authors.lastname: Pathirana
authors.affiliation: Departments of Pediatrics, Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Flor M
authors.initials: FM
authors.lastname: Muñoz
authors.affiliation: Global Clinical Research & Development - Epidemiology Novartis/GSK Vaccines, Amsterdam, The Netherlands.
authors.forename: Victoria
authors.initials: V
authors.lastname: Abbing-Karahagopian
authors.affiliation: Program for Appropriate Technology in Health (PATH), Seattle, USA.
authors.forename: Niranjan
authors.initials: N
authors.lastname: Bhat
authors.affiliation: Immunization and Vaccine Preventable Diseases, Public Health Ontario, Canada.
authors.forename: Tara
authors.initials: T
authors.lastname: Harris
authors.affiliation: Immunization Technical Support Unit - Ministry of Health and Family Welfare, Public Health Foundation of India, New Delhi, India.
authors.forename: Ambujam
authors.initials: A
authors.lastname: Kapoor
authors.affiliation: Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ontario, Canada.
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Keene
authors.affiliation: Tufts University School of Medicine, Boston, MA, USA.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Mangili
authors.affiliation: Division of Neonatology, The Children's Hospital of Philadelphia and University of Pennsylvania, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Padula
authors.affiliation: Ministry of Health Uganda, Soroti Regional Referral Hospital, Uganda.
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Pande
authors.affiliation: Sanofi Pasteur Inc., Swiftwater, PA, USA.
authors.forename: Vitali
authors.initials: V
authors.lastname: Pool
authors.affiliation: School of Population and Public Health, University of British Columbia, Vancouver, Canada.
authors.forename: Farshad
authors.initials: F
authors.lastname: Pourmalek
authors.affiliation: Independent Consultant, Vaccinologist, USA.
authors.forename: Frederick
authors.initials: F
authors.lastname: Varricchio
authors.affiliation: Global Healthcare Consulting, New Delhi, India.
authors.forename: Sonali
authors.initials: S
authors.lastname: Kochhar
authors.affiliation: Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa; Department of Science and Technology, National Research Foundation, Vaccine Preventable Diseases, South Africa; Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: contact@brightoncollaboration.org.
authors.forename: Clare L
authors.initials: CL
authors.lastname: Cutland
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic; D003625:Data Collection; D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D009017:Morbidity; D009035:Mothers; D066087:Perinatal Death; D011247:Pregnancy; D013223:Statistics as Topic; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D014612:Vaccines
keywords: Adverse event; Case definition; Guidelines; Maternal immunization; Neonatal death