Josephine van Dongen

5 Safety and Tolerability of Human Rotavirus Vaccination 133 Secondary outcomes Results of the secondary endpoints are presented in table S2 . The mean cumulative number of solicited AE during the primary series of NIP was 1.77 compared to 1.97 for NIP+HRV vaccinated infants. Table S2 . Solicited AE for receipt of the primary series with or without HRV per infant ( ≥ 27 weeks of gestational age) Repor ted adverse events associated with receipt of primary series NIP vaccinated infants (N=471) NIP+HRV vaccinated infants (N=570) p-value Any solicited adverse event 332 (70.5%) 404 (70.9%) 0.89 Fever 152 (32.3%) 191 (33.5%) 0.67 Gastrointestinal adverse event 66 (14.0%) 144 (25.3%) <0.001 Any AE related healthcare attendance 48 (10.2%) 51 (8.9%) 0.47 Statistical significance (p-value <0.05) is highlighted in bold.Abbreviations: HRV = human rotavirus vaccine, N = number in group, NIP = national immunization program. Table S3 . Baseline characteristics and solicited AE for receipt of primary series with or without HRV per infant, for off-label subgroup of high-risk premature infants (gestational age < 27 weeks) Characteristic NIP vaccinated (N=5) NIP + HRV vaccinated (N=22) Gestational age in weeks+days (mean, SD) 26+1 (0+4) 26+0 (0+5) Bir thweight in grams (median, IQR) 925 (805-1045) 820 (523-1199) Small for gestational age (yes,%) £ 0 3 (13.6) Sex (male, %) 2 (40.0) 12 (54.5) Multiple birth (yes, %) 0 6 (27.3) Congenital pathology (yes, %) 0 0 Age at first vaccination in days (median, IQR) 63 (54-72) 72 (45-99) Concomitant NIP+HRV administration NA 10 (45.5) Sibling (yes, %) 1 (20.0) 4 (18.2)