title: Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety data.
abstract: Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and post-implementation programmes of immunisations in pregnancy.
authors.affiliation: SAEFVIC, Murdoch Childrens Research Institute, Victoria, Australia; Infection and Immunity, Monash Children's Hospital, Department of Paediatrics, The Ritchie Centre, Hudson Institute, Monash University, Australia.
authors.forename: Julie-Anne
authors.initials: JA
authors.lastname: Quinn
authors.affiliation: Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Flor M
authors.initials: FM
authors.lastname: Munoz
authors.affiliation: Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI, USA.
authors.forename: Bernard
authors.initials: B
authors.lastname: Gonik
authors.affiliation: LMF Pharmacoepidemiology, New York, USA.
authors.forename: Lourdes
authors.initials: L
authors.lastname: Frau
authors.affiliation: Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Clare
authors.initials: C
authors.lastname: Cutland
authors.affiliation: Global Pharmacovigilance, Sanofi Pasteur, Swiftwater, Philadelphia, USA.
authors.forename: Tamala
authors.initials: T
authors.lastname: Mallett-Moore
authors.affiliation: Department of Pediatrics, Souro Sanou Teaching Hospital, Bobo-Dioulasso, Burkina Faso.
authors.forename: Aimee
authors.initials: A
authors.lastname: Kissou
authors.affiliation: Debiopharm International SA, Lausanne, Switzerland.
authors.forename: Frederick
authors.initials: F
authors.lastname: Wittke
authors.affiliation: INCLEN Trust International, India.
authors.forename: Manoj
authors.initials: M
authors.lastname: Das
authors.affiliation: Optum Epidemiology, Providence, RI, USA.
authors.forename: Tony
authors.initials: T
authors.lastname: Nunes
authors.affiliation: Communicable Disease Prevention and Control, Nova Scotia, Canada.
authors.forename: Savia
authors.initials: S
authors.lastname: Pye
authors.affiliation: Pfizer Inc, Collegeville, PA, USA.
authors.forename: Wendy
authors.initials: W
authors.lastname: Watson
authors.affiliation: Dirección General de Salud Pública, Avd Cataluña n°21, 46020 Valencia, Spain.
authors.forename: Ana-Maria Alguacil
authors.initials: AA
authors.lastname: Ramos
authors.affiliation: University of Puerto Rico Graduate School of Public Health, Medical Sciences Campus, San Juan 00935, Puerto Rico.
authors.forename: Jose F
authors.initials: JF
authors.lastname: Cordero
authors.affiliation: Taiwan Centers for Disease Control, Taipei, Taiwan.
authors.forename: Wan-Ting
authors.initials: WT
authors.lastname: Huang
authors.affiliation: Global Healthcare Consulting, India.
authors.forename: Sonali
authors.initials: S
authors.lastname: Kochhar
authors.affiliation: SAEFVIC, Murdoch Childrens Research Institute, Victoria, Australia; Infection and Immunity, Monash Children's Hospital, Department of Paediatrics, The Ritchie Centre, Hudson Institute, Monash University, Australia. Electronic address: contact@brightoncollaboration.org.
authors.forename: Jim
authors.initials: J
authors.lastname: Buttery
mesh_terms: D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D007234:Infant, Premature; D009017:Morbidity; D011203:Poverty; D011247:Pregnancy; D047928:Premature Birth; D013223:Statistics as Topic
keywords: Adverse event; Antenatal; Case definition; Guidelines; Immunisation; Preterm birth