Josephine van Dongen

Chapter 5 132 Supplementary Material Appendix A Table S1 . Detailed information on vaccine related SAE and hospitalized vaccine failure after first and second HRV administration Nr Event Sex Gesta- tional age in weeks + days Bir th weight in grams Cong- enital disor- der Age at HRV1 * Age at HRV2 * Age at SAE * Rota- virus positive feces sample 2 Severe AGE M 32+3 2000 no 52 55 3 Intussus ception F 33+5 1500 no 49 120 124 4 Cardio- resp inci- dents F 30+3 1300 no 50 80 51 5 Sepsis F 28+4 800 no 56 91 92 6 NEC M 27+4 1000 no 58 62 no 7 Lactose intole- rance M 32+0 1600 no 68 120 120 8 NEC M 33+1 2000 yes 68 68 yes 10 Intussus ception F 33+0 1500 no 95 126 127 11 Cardio- resp inci- dents F 28+3 700 no 58 108 109 13 Cardio- resp inci- dents M 27+3 2900 yes 99 99 16 Vaccine Failure M 27+2 800 no 109 144 344 yes (Geno- type G3P8) 17 Vaccine Failure M 31+6 1800 no 51 125 384 yes (Geno- type G9P8) * Age in days. Abbreviations: M=male, F=female, SAE = serious adverse event, HRV = human rotavirus vaccine, AGE = acute gastroenteritis, Cardio-resp = cardiorespiratory events, NEC=necrotizing enterocolitis, HRV1 = first dose, HRV2 = second dose.