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weeks",{"label":13,"type":10,"description":14,"interventionNames":10},"healthy controls","healthy term infants",[16,20],{"name":17,"affiliation":18,"role":19},"Gertjan Driessen, Prof MD PhD","Maastricht UMC","STUDY_DIRECTOR",{"name":21,"affiliation":22,"role":23},"Jantien Bolt-Wieringa, MD","Medical Center Haaglanden","PRINCIPAL_INVESTIGATOR",[25,29],{"name":17,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+31433876543","gertjan.driessen@mumc.nl",{"name":21,"role":26,"phone":30,"phoneExt":10,"email":31},"+310889792330","j.boltwieringa@haaglandenmc.nl",[33,49,62,75,88,98,108],{"facility":34,"status":35,"city":36,"state":10,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Amphia Hospital","RECRUITING","Breda","4819 EV","Netherlands",{"type":40,"coordinates":41},"Point",[42,43],4.77596,51.58656,{"lat":43,"lon":42},[46],{"name":47,"role":26,"phone":48,"phoneExt":10,"email":10},"Ron Beek van, MD, 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DB",{"type":40,"coordinates":113},[114,115],5.40278,51.41833,{"lat":115,"lon":114},[118],{"name":119,"role":26,"phone":120,"phoneExt":10,"email":10},"Jacqueline van der Sluijs-Bens, MD","+31(0)408880000",{"type":122,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[124,125,126,127,128,129,130,132,134,137,139],{"name":22,"class":6},{"name":34,"class":6},{"name":63,"class":6},{"name":89,"class":6},{"name":99,"class":6},{"name":109,"class":6},{"name":131,"class":6},"Reinier de Graaf Groep",{"name":133,"class":6},"Erasmus Medical Center",{"name":135,"class":136},"Merck Sharp & Dohme LLC","INDUSTRY",{"name":138,"class":6},"Zuyderland Medical Centre",{"name":140,"class":6},"Haga Hospital","100459749",false,"NCT05266664","Preterm Immune System Development and Response to Immunization","PRIMI","To be eligible to participate in this study, a preterm infant must meet all following criteria:\n\n* Preterm infant born at gestational age less than 32 weeks (whose mothers did or did not receive a T dap vaccination during pregnancy)\n* Parents\u002F guardians must have sufficient understanding of the Dutch language\n\nTo be eligible to participate in this study, a healthy full-term infant must meet all following criteria:\n\n* healthy full-term infant whose mother received a Tdap vaccination during pregnancy\n* Parents\u002F guardians must have sufficient understanding of the Dutch language\n\nTo be eligible to participate in this study, a mother must meet all following criteria:\n\n\\- Mother of preterm or health full-term infant who are participating in the study\n\nExclusion Criteria:\n\n* Parents\u002Fguardians of the infant are not able or willing to provide informed consent\n* Infant with congenital anomaly which are more likely to cause adverse effects after immunization (for example hemodynamically significant congenital heart defect)\n* Infant with a (possible) HIV infection or immunodeficiency\n* Maternal use of immunosuppressive drugs during pregnancy",true,"ALL","1 Day","2 Months",{"count":152,"type":153},145,"ESTIMATED","OBSERVATIONAL","In this study the response to vaccination and development of the immune system in very preterm infants upon the current vaccination schedule will be compared to healthy term infants.",[157,158,159],"Immune System Disorder","Preterm","Vaccination Failure",[161,162,163],"immune system development","preterm infant","vaccination","2024-03-19",{"date":166,"type":167},"2024-03-20","ACTUAL",{"date":169,"type":167},"2022-12-08",{"date":171,"type":153},"2026-07",{"name":5,"class":6},7]