{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T09:22:48Z","timestamp":1785576168924,"version":"3.56.0"},"reference-count":36,"publisher":"American Academy of Pediatrics (AAP)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,12,1]]},"abstract":"<jats:sec>\n                  <jats:title>OBJECTIVES<\/jats:title>\n                  <jats:p>Rotavirus vaccination has 87% to 100% effectiveness against severe rotavirus acute gastroenteritis (AGE) in healthy infants in high-income countries. Little is known whether infants with medical risk conditions (MRCs) are equally protected and if the vaccine is equally well tolerated. We conducted a quasi-experimental prospective multicenter before-after cohort study to assess the vaccine effectiveness (VE) and safety profile of the human rotavirus vaccine (HRV) among MRC infants that required prolonged or frequent postnatal care.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>METHODS<\/jats:title>\n                  <jats:p>The Netherlands has no national rotavirus immunization program, but HRV was implemented in routine care for MRC infants in 13 Dutch hospitals. Participants in the before and after cohort, HRV unvaccinated and vaccinated, respectively, were followed for occurrence of (rotavirus) AGE. VE of at least 1 dose was estimated by using time-to-event analysis for severe rotavirus AGE. Vaccine-related serious adverse event (AEs) after HRV were retrieved systematically from medical charts. Solicited AEs after vaccinations were prospectively collected and compared between vaccination time points with or without HRV.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>In total, 1482 high-risk infants with MRC were enrolled, including 631 in the before and 851 in the after cohorts; 1302 infants were premature (88.3%), 447 were small for gestational age (30.2%), and 251 had at least 1 congenital disorder (17.0%). VE against severe rotavirus AGE was 30% (95% confidence interval [CI]: \u221236% to 65%). Overall, the observed number of rotavirus hospitalizations was low and not significantly different between the cohorts (2 and 2, respectively). The rate of vaccine-related serious AE was 0.24 per 100 vaccine doses. The adjusted risk ratio for any AE after HRV vaccination compared with other routine vaccinations was 1.09 (95% CI: 1.05 to 1.12) for concomitant administration and 0.91 (95% CI: 0.81 to 0.99) for single HRV administration. Gastrointestinal AEs were 10% more frequent after HRV.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>In contrast to previous findings among healthy term infants, in routine use, HRV offered limited protection to vulnerable medical risk infants. HRV is generally well tolerated in this group in single administration, but when coadministered with routine vaccines, it is associated with higher risk of (mostly gastrointestinal) AE. Our study highlights the importance of studying vaccine performance in subgroups of medically vulnerable infants.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1542\/peds.2021-051901","type":"journal-article","created":{"date-parts":[[2021,11,24]],"date-time":"2021-11-24T00:17:53Z","timestamp":1637713073000},"source":"Crossref","is-referenced-by-count":10,"title":["Rotavirus Vaccine Safety and Effectiveness in Infants With High-Risk Medical Conditions"],"prefix":"10.1542","volume":"148","author":[{"given":"Josephine A.P.","family":"van Dongen","sequence":"first","affiliation":[{"name":"aJulius Center for Health Sciences and Primary Care, Epidemiology of Infectious Diseases"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elsbeth D.M.","family":"Rouers","sequence":"additional","affiliation":[{"name":"aJulius Center for Health Sciences and Primary Care, Epidemiology of Infectious Diseases"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"},{"name":"bNational Institute for Public Health and the Environment, Center for Infectious Disease Control, Bilthoven, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rob","family":"Schuurman","sequence":"additional","affiliation":[{"name":"cDepartments of Medical Microbiology"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caterina","family":"Band","sequence":"additional","affiliation":[{"name":"dDepartment of Pediatrics, Spaarne Gasthuis, Haarlem and Hoofddorp, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shannon M.","family":"Watkins","sequence":"additional","affiliation":[{"name":"aJulius Center for Health Sciences and Primary Care, Epidemiology of Infectious Diseases"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marlies A.","family":"van Houten","sequence":"additional","affiliation":[{"name":"dDepartment of Pediatrics, Spaarne Gasthuis, Haarlem and Hoofddorp, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louis J.","family":"Bont","sequence":"additional","affiliation":[{"name":"ePediatrics, University Medical Center Utrecht, Utrecht, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Obbe F.","family":"Norbruis","sequence":"additional","affiliation":[{"name":"fDepartment of Pediatrics, Isala Hospital, Zwolle, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marieke A.C.","family":"Hemels","sequence":"additional","affiliation":[{"name":"fDepartment of Pediatrics, Isala Hospital, Zwolle, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gijs T.J.","family":"van Well","sequence":"additional","affiliation":[{"name":"gDepartment of Pediatrics, Maastricht University Medical Centre, Maastricht, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arine M.","family":"Vlieger","sequence":"additional","affiliation":[{"name":"hDepartment of Pediatrics, St Antonius Hospital, Nieuwegein, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline","family":"van der Sluijs","sequence":"additional","affiliation":[{"name":"hDepartment of Pediatrics, St Antonius Hospital, Nieuwegein, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helene G.","family":"Stas","sequence":"additional","affiliation":[{"name":"jDepartment of Pediatrics, Maasstad Hospital, Rotterdam, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerdien","family":"Tramper-Stranders","sequence":"additional","affiliation":[{"name":"kDepartment of Pediatrics, Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elly A.","family":"Kleinlugtenbeld","sequence":"additional","affiliation":[{"name":"lDepartment of Pediatrics, Albert Schweitzer Hospital, Rotterdam, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne A.M.W.","family":"van Kempen","sequence":"additional","affiliation":[{"name":"mDepartment of Pediatrics, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margreet","family":"Wessels","sequence":"additional","affiliation":[{"name":"nDepartment of Pediatrics, Rijnstate Hospital, Arnhem, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maaike C.","family":"van Rossem","sequence":"additional","affiliation":[{"name":"nDepartment of Pediatrics, Rijnstate Hospital, Arnhem, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carin A.C.M.","family":"Dassel","sequence":"additional","affiliation":[{"name":"oDepartment of Pediatrics, Deventer Hospital, Deventer, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dasja","family":"Pajkrt","sequence":"additional","affiliation":[{"name":"pDepartment of Pediatrics, Amsterdam University Medical Centre, Amsterdam, Netherlands"},{"name":"iDepartment of Pediatrics, Maxima Medical Centre, Veldhoven, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc J.M.","family":"Bonten","sequence":"additional","affiliation":[{"name":"aJulius Center for Health 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Vaccine Access Center\n          . Current rotavirus vaccine intro status. 2018. Available at: https:\/\/view-hub.org\/map\/?set=current-vaccine-intro-status&category=rv&group=vaccine-introduction. 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Netherlands Trial Register. 2014. Available at: https:\/\/www.trialregister.nl\/trial\/5213. 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