Table 1.

Summary of findings for rotavirus efficacy against severe RVGE in high mortality countries in Africa and Asia.

Vaccine	Absolute risk reduction (95% CI)*	Vaccine efficacy (95% CI)	N° of participants & studies	Certainty of the evidence (GRADE)†
One-year follow-up
RotaTeq™	17 (11 to 21) fewer cases per 1000 children	57% (36 to 71)	6775 participants in 5 RCTs [12], [13]	⊕⊕⊕⊕ HIGH
Rotarix™	17 (13 to 20) fewer cases per 1000 children	57% (43 to 68)	8623 participants in 5 RCTs [14], [15], [16], [17]	⊕⊕⊕⊕ HIGH
Rotavac®	17 (12 to 21) fewer cases per 1000 children	57% (40 to 70)	6799 participants in 1 RCT [18]	⊕⊕⊕⊕ MODERATE a
Rotasiil™	14 (6 to 20) fewer cases per 1000 children	48% (19 to 67)	11,008 participants in 2 RCTs [19], [20]	⊕⊕⊕⊕ HIGH
Two-years follow-up
RotaTeq™	22 (12 to 30) fewer cases per 1000 children	44% (23 to 59)	6744 participants in 5 RCTs [12], [13]	⊕⊕⊕⊕ HIGH
Rotarix™	15 (4 to 23) fewer cases per 1000 children	29% (8 to 45)	6183 participants in 3 RCTs [15], [17]	⊕⊕⊕⊕ HIGH
Rotavac®	27 (20 to 33) fewer cases per 1000 children	54% (40 to 65)	6541 participants in 1 RCT [18]	⊕⊕⊕⊕ MODERATE a
Rotasiil™	22 (13 to 29) fewer cases per 1000 children	44% (26 to 58)	11,008 participants in 2 RCTs [19], [20]	⊕⊕⊕⊕ HIGH

^*Assumed risk of severe RVGE in the control groups of 30 per 1000 children in the first year and 50 per 1000 children in the second year. Numbers in brackets represent 95% confidence intervals.

^†The GRADE approach considers the following factors for downgrading the certainty of the evidence: limitations in the study design; inconsistency of results; indirectness of evidence; imprecision; and publication bias.

^aDowngraded by one level for indirectness: single trial conducted in one country, so estimate may not apply to other high-mortality countries.