Josephine van Dongen

5 Safety and Tolerability of Human Rotavirus Vaccination 125 differences were observed in the frequency of related healthcare attendance between NIP only, concomitant NIP+HRV or, HRV only administrations. The adjusted RR for at least one solicited AE in the seven-day post-vaccination period was 1.07 (95%CI 1.04-1.10) for concomitant NIP+HRV versus NIP only and 0.90 (95%CI 0.80-0.98) for HRV only vaccination ( table 3 ). The final model included GA, presence of a sibling in the household and, age at vaccination as covariates.The interaction term for GA was not statistically significant. Analysis of the number of AE per vaccine administration yielded comparable results with an adjusted IRR of 1.07 (95% CI 0.96-1.19) for NIP+HRV versus NIP only ( table 3 ). GA, sibling and, age at vaccination were included in the model. Table 2 . Solicited AE following receipt of NIP vaccines, concomitant NIP+HRV or HRV only vaccination as par t of the primary series in high-risk premature infants ( ≥ 27 weeks of gestational age) Repor ted adverse events NIP only vacci- nation N=1233 Concomitant NIP +HRV vaccination N=305 HRV only vacci- nation N=176 p-value At least one solicited adverse event 558 (45.5%) 170 (55.7%) 63 (36.4%) <0.00 Fever 213 (17.3%) 60 (19.7%) 9 (5.2%) <0.00 Gastrointestinal 74 (6.0%) 50 (16.4%) 30 (17.0%) <0.00 Mean number of solicited adverse events 1.49 (SD 0.81) 1.55 (SD 0.76) 1.79 (SD 0.97) <0.00 * Number of solicit- ed AE 1 2 >2 363 (29.6%) 139 (11.3%) 56 (4.6%) 101 (33.1%) 47 (15.4%) 22 (7.2%) 31 (17.9%) 20 (11.6%) 12 (7.0%) 0.08 Any AE related healthcare atten- dance 59 (4.8%) 15 (4.9%) 7 (4.0%) 0.78 # Type of healthcare General prac titioner Outpatient clinic Emergency room Hospitalization 18 (1.5%) 7 (0.6%) 12 (1.0%) 32 (2.6%) 2 (0.7%) 2 (0.7%) - 12 (3.9%) 4 (2.3%) 1 (0.6%) 1 (0.6%) 3 (1.7%) 0.18 # Statistical significance (p-value <0.05) is highlighted in bold. * ANOVA test. # Fisher Exact test.Abbreviations: HRV = human rotavirus vaccine, N = number in group, NIP = national immunization program.