Josephine van Dongen

Chapter 5 124 Table 1 . Baseline table of vaccinated infants with gestational age ≥ 27 weeks Characteristic NIP vaccinated (N=471) NIP + HRV vaccinated (N=570) p-value Gestational age in weeks+days (mean, SD) 32+1 (2+4) 32+3 (2+4) 0.07 Gestation subgroups 27-30 weeks 30-37 weeks 113 (24.0) 358 (76.0) 116 (20.4) 454 (79.6) 0.16 Bir thweight in grams (median, IQR) 1770 (840-2700) 1780 (990-2570) 0.80 Small for gestational age (yes,%) £ 135 (28.7) 180 (31.6) 0.31 Sex (male, %) 269 (57.1) 301 (52.8) 0.17 Multiple birth (yes, %) 122 (25.9) 157 (27.2) 0.64 Congenital pathology (yes, %) 38 (8.1) 48 (8.4) 0.84 Number of disorders 1 (%) 2 (%) >2 30 (78.9) 5 (13.1) 3 (7.9) 42 (87.5) 6 (12.5) - 0.49 Age at first vaccination in days (median, IQR) 61 (48-74) 59 (40-78) <0.001 * Sibling (yes, %) 99 (21.5) 120 (21.4) 0.97 Parental education # High Medium Lower 342 (73.5) 104 (22.4) 19 (4.1) 422 (75.4) 123 (22.0) 15 (2.7) 0.44 Parental background ^ European Non-European Mixed 399 (85.6) 25 (5.4) 42 (9.0) 477 (85.0) 28 (5.0) 56 (10.0) 0.85 Average parental age in years (median, IQR) 32.5 (27.0-38.0) 33.0 (27.0-39.0) 0.41 Percentages are derived excluding subjects with missing data on the variable. Statistical significance (p-value <0.05) is highlighted in bold. * Rank-sum test. £ Based on 10th percentile perinatal growth curves. 14 # Based on highest parental educational level. ^ Based on parental background and categorized according to world population by country. 15 Abbreviations: HRV = human rotavirus vaccine, N = number in group, SD = standard deviation, IQR = interquar tile range. Overall, there was a 10% difference in occurrence of any solicited AE following NIP (45.5%) versus NIP+HRV (55.7%) vaccine administration, table 2 . AE were repor ted less frequently for HRV only administration (36.4%), largely due to a reduced frequency of fever (5.2%). Gastrointestinal AE were more frequent after HRV only administration (16.4%) and after concomitant NIP+HRV administration (17.0%) compared to NIP vaccination (6.0%). No