Table 2:

Evidence in Humans: Rotavirus Vaccines

Study	Design	Location	Study Population	Main Findings
Vaarala et al., 2017	Cohort	Finland	94,437 children vaccinated against rotavirus; 27,213 children not vaccinated against rotavirus; all from 2009 – 2010 birth cohort	Vaccination against rotavirus not significantly associated with T1D incidence in the first 4 – 6 years following vaccination (Risk Ratio [RR] for full-series vs. no vaccination: 0.91; 95% Confidence Interval [CI]: 0.69 – 1.20)
Hemming-Harlo et al., 2019	Cohort	Finland (REST trial population)	3184 children who had received the study vaccine in the original trial; 2580 children who had received the placebo vaccine	Vaccination against rotavirus not significantly associated with prevalence of T1D when assessed 12 – 14 years following vaccination (Prevalence 0.97% in placebo group and 1.04% in vaccine group; p = 0.81)
Perrett et al., 2019	Ecological	Australia	16,159 cases of incident T1D among 66,055,000 person-years of observation in children <14, 2000 – 2015	Significant decrease in T1D incidence among children 0 – 4 when comparing post-rotavirus-vaccine years to pre-rotavirus-vaccine years (Rate Ratio [IRR]: 0.85; 95% CI: 0.75 – 0.97)
Rogers et al., 2019	Cohort	United States	540,317 fully rotavirus vaccinated children; 140,646 partially rotavirus vaccinated children; 246,600 children unvaccinated against rotavirus; 546,972 children born before rotavirus vaccine introduction (historical comparator); all with private health insurance	T1D incidence significantly lower in vaccinated children vs. concurrent and historical unvaccinated groups (Hazard Ratio [HR] for full-series vs. no vaccination concurrent comparators: 0.67; 95% CI: 0.54 – 0.83)
Burke et al., 2020	Cohort	United States	1,035,198 fully rotavirus vaccinated children; 210,057 partially rotavirus vaccinated children; 318,285 children unvaccinated against rotavirus; all with employer-sponsored commercial health insurance.	Vaccination against rotavirus not significantly associated with T1D incidence in children followed up to 12 years of age (HR for full-series vs. no vaccination: 1.09; 95% CI: 0.87 – 1.36)
Glanz et al., 2020	Cohort	United States	360,169 fully rotavirus vaccinated children; 15,765 partially rotavirus vaccinated children; 11,003 children unvaccinated against rotavirus; all enrolled in a health plan participating in the Vaccine Safety Datalink project	Vaccination against rotavirus not significantly associated with T1D incidence in children followed up to 11 years of age (HR: 1.03; 95% CI: 0.62 – 1.72)