Josephine van Dongen

Chapter 5 126 Table 3 . Outcome estimates Unadjusted esti- mate 95% CI Adjusted esti- mate * 95% CI NIP only vacci- nation Ref - Ref - At least one solicited AE after concomitant NIP+HRV vacci- nation RR 1.07 1.03-1.10 RR 1.07 1.04-1.10 At least one solic- ited AE after HRV only vaccination RR 0.90 0.79-0.98 RR 0.90 0.80-0.98 Number of solicited AE after NIP+HRV vacci- nation IRR 1.06 0.96-1.18 IRR 1.07 0.96-1.19 * Adjusted for age at vaccination (in months), older sibling in household, gestational age in weeks. Abbreviations: RR = relative risk, IRR = incidence rate ratio CI = confidence interval, NIP = national immunization program, HRV = human rotavirus vaccine. Results of secondary outcomes are presented in appendix A, table S2 . A total of 736 infants (70.7%) repor ted any solicited AE in the seven-day post-vaccination period during completion of the primary series with or without HRV and 99 (9.5%) infants had any AE related healthcare contact. Characteristics for infants with GA <27 weeks were relatively similar with the exception of older age at vaccination for HRV vaccinated infants (72 versus 63 days), shown in table S3 of Appendix A.Tolerability for infants with a GA below 27 weeks is different than for those born past 27 weeks of gestation, fewer AE were repor ted, however numbers are small (see appendix A table S3 and S4 ). The tolerability among 134 term infants with congenital disorders was similar as among high- risk premature infants of ≥ 27 weeks GA and is described in appendix B . Exploration of potential bias induced by complete case analyses are shown in appendix A, table S5 . There were statistical significant less infants born as twins among those with missing information, and average parental age was lower as was family educational level. Discussion Our findings indicate that about one in 200 high-risk premature infants experienced a vaccine related SAE following a two-dose HRV course that was associated with hospitalization, increased length of hospital stay or life suppor t intervention, but all resolved without long-term sequelae. Administration of HRV with or without concomitant administration of NIP vaccines was