Josephine van Dongen

Chapter 8 190 Table 1 . Differences in study -procedures, -population and -period between RIVAR and prior positive rotavirus vaccine effectiveness studies RIVAR IVANHOE 17 Dahl et al 18 Study procedures Design Before-after cohor t Active hospital based surveillance Longitudinal administra- tive data Data collection Prospective Prospective Retrospective Vaccine Rotarix RotaTeq RotaTeq and Rotarix Exposure At least one dose Vaccine introduction Receipt of at least one dose rotavirus vaccination Adjustment Seasonal variation by rotavirus detections from weekly sentinel surveillance Variation in rotavirus epidemiology by using an unvaccinated pop- ulation Seasonal trends by bir th month-year in annual and peak season Statistical analysis Cox regression Poisson regression Poisson regression Outcome Severe rotavirus AGE Rotavirus hospitaliza- tion Rotavirus hospitaliza- tion Study population Inclusion criteria Premature infants 24- 36+6 weeks Low bir thweight Congenital disorders Or combination of all above Premature infants 25- 36+6 (very) Low bir thweight <1500 or <2500 grams Gestational age Mean (SD): 32+5 weeks+days (3+5) Median (range): 34.7 weeks (30.2-35.6) n/a Bir thweight Median (IQR): 1830 g (822-2838) Median (range): 2320 g (1575-2670) n/a Number of par ticipants 1482 217 78,288 Vaccination coverage 84.5% 41.9-45.2% 64-82% Outcome events 38 27 n/a Main outcome estimate 30% (95%CI -36;65%) 62% (95%CI 45;73%) 90-100% (95%CI n/a) Study period Time 2014-2019 2002-2010 2001-2015 Country The Netherlands France Nor th-America Circulating rotavirus strains G2P4, G3P8, G9P8, G4P8 19–21 G1P8, G9P8 22 G1P8, G3P8 23 , G12P8 24,25 Universal rotavirus vaccination No Within study area, from 2007 onwards Yes, from 2006 on- wards Abbreviations:AGE= acute gastroenteritis, SD = standard deviation, n/a = not available, IQR = interquar tile range, CI = confidence interval.

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