Josephine van Dongen

Chapter 4 102 Co-primary outcome 1. The adjusted HR for severe rotavirus AGE was 0.70 (95%CI 0.35;1.40) for rotavirus vaccinated versus unvaccinated infants in ATP analysis, resulting in a VE of 30% (95%CI -36%;65%) after at least one dose of HRV. Attending daycare and an increase in rotavirus epidemic intensity significantly increased the hazard of severe rotavirus AGE. Characteristics of these severe rotavirus AGE are presented in appendix table S2. 2. The impact of the selective HRV vaccination program defined as the relative reduction in rotavirus related hospitalization in the post-implementation versus pre-implementation period was 24%, RR 0.76 (95%CI 0.10;6.37). Outcome estimates of primary, secondary and post-hoc analyses are presented in table 3. Secondary and pre-specified subgroup analyses are described more elaborate in the appendix. Table 2. AGE events during follow-up in ITT and ATP before-after cohor ts Intention to treat (ITT) According to protocol (ATP) Pre-implemen- tation period: all infants N=631 $ Post-implemen- tation period: all infants N=851 $ Pre-implemen- tation: willing to vaccinate N=496 Post-implementa- tion: vaccinated N=719 All-cause AGE Any AGE 549 674 499 597 Severe AGE 68/252 (27.0%) 79/227 (25.8%) 62/228 (27.2%) 71/279 (25.4%) AGE hospitaliza- tion 43 (7.8%) 64 (9.5%) 42 (8.4%) 58 (9.7%) Rotavirus AGE Any rotavirus AGE 49 68 47 67 Severe rotavirus AGE 18/42 (42.9%) 20/64 (31.3%) 17/39 (43.6%) 17/59 (28.8%) Rotavirus hospital- ization 2 (4.1%) 2 (2.9%) 2 (4.3%) 2 (3.0%) Denominator changes for categories of severe all-cause and severe rotavirus AGE episodes, due to missing data on severity if AGE was unrepor ted. Abbreviations: AGE = acute gastroenteritis.