Josephine van Dongen

Chapter 5 118 Abstract Objective : Rotavirus vaccination is recommended for prevention of severe rotavirus disease. While the vaccine is well tolerated in healthy term infants, there are limited data on premature infants.We aim to assess the safety and tolerability among infants born between 27-37 weeks of gestation in need of prolonged postnatal medical care. Methods: The Netherlands has no national rotavirus immunization program, but selective human rotavirus vaccination (HRV) for high-risk premature infants was implemented in par ticipating hospitals. HRV vaccination and occurrence of any vaccine related serious adverse event (SAE) was systematically documented. As secondary endpoints solicited adverse events (AE) following administration of national immunization program (NIP) vaccines with or without HRV were prospectively collected. Results : Among 2077 rotavirus vaccinated infants, ten vaccine related SAE were documented, resulting in hospital admission or prolonged hospitalization. There were no deaths and all infants recovered. The adjusted risk ratio (RR) for any AE following concomitant NIP+HRV administration was 1.07 (95%CI 1.04-1,10) and, for HRV administration alone RR was 0.90 (95% CI 0,80-0.98), compared to NIP administration. Gastrointestinal AE were statistically significant repor ted more often after receiving HRV (p-value <0,001). Conclusion : Among vulnerable premature infants, vaccine related SAE were repor ted in 0.25 per 100 HRV vaccine doses. HRV is generally well tolerated when co-administered with NIP vaccines, but associated with approximately ten percent higher risk of gastrointestinal AE.