Comparison 3. Rotavac versus placebo.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Rotavirus diarrhoea: severe (up to 1 year follow‐up)	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2 Rotavirus diarrhoea: severe (up to 2 years follow‐up)	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3 All‐cause diarrhoea: severe cases (up to 1 year follow‐up)	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
4 All‐cause death	2	8155	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.52, 1.62]
5 All serious adverse events	3	8210	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.85, 1.02]
6 Serious adverse events: intussusception	4	8582	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.35, 5.02]
7 Rotavirus diarrhoea: of any severity (up to 1 year follow‐up)	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
8 Rotavirus diarrhoea: of any severity (up to 2 years follow‐up)	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
9 Rotavirus diarrhoea: requiring medical attention	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
9.1 Up to 1 year follow‐up (at least 1 rotavirus season)	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 Reactogenicity: fever	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
10.1 After dose 1	2	427	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.35, 1.94]
10.2 After dose 2	1	356	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.33, 1.77]
10.3 After dose 3	1	358	Risk Ratio (M‐H, Fixed, 95% CI)	1.11 [0.52, 2.36]
11 Reactogenicity: diarrhoea	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
11.1 After dose 1	2	427	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.62, 1.30]
11.2 After dose 2	1	356	Risk Ratio (M‐H, Fixed, 95% CI)	1.55 [1.00, 2.41]
11.3 After dose 3	1	358	Risk Ratio (M‐H, Fixed, 95% CI)	4.09 [2.11, 7.92]
12 Reactogenicity: vomiting	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
12.1 After dose 1	2	427	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [0.71, 2.55]
12.2 After dose 2	1	356	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [0.64, 3.66]
12.3 After dose 3	1	358	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.39, 2.66]
13 Immunogenicity: rotavirus vaccine shedding (end of follow‐up)	2	427	Risk Ratio (M‐H, Random, 95% CI)	9.86 [2.58, 37.63]
14 Immunogenicity: seroconversion	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
14.1 After dose 1	1	121	Risk Ratio (M‐H, Fixed, 95% CI)	3.58 [2.03, 6.29]
14.2 After dose 2	1	117	Risk Ratio (M‐H, Fixed, 95% CI)	2.97 [1.78, 4.98]
14.3 After dose 3	3	1699	Risk Ratio (M‐H, Fixed, 95% CI)	2.82 [2.26, 3.51]
15 Dropouts before the end of the trial	3	8215	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.62, 1.06]
16 Subgroup analysis: severe cases of rotavirus diarrhoea by G and P types (up to 1 year follow‐up)	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
16.1 G1P[8]	1	6541	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.36, 1.20]
16.2 G2P[4]	1	6541	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.22, 0.69]
16.3 G12P[6]	1	6541	Risk Ratio (M‐H, Fixed, 95% CI)	0.31 [0.13, 0.74]
16.4 G12P[8]	1	6541	Risk Ratio (M‐H, Fixed, 95% CI)	0.30 [0.07, 1.26]
17 Subgroup analysis: severe cases of rotavirus diarrhoea by G and P types (up to 2 years follow‐up)	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
17.1 G1P[8]	1	6541	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.38, 0.93]
17.2 G2P[4]	1	6541	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.23, 0.62]
17.3 G9P[4]	1	6541	Risk Ratio (M‐H, Fixed, 95% CI)	4.52 [0.57, 35.66]
17.4 G12P[6]	1	6541	Risk Ratio (M‐H, Fixed, 95% CI)	0.31 [0.13, 0.74]
17.5 G12P[8]	1	6541	Risk Ratio (M‐H, Fixed, 95% CI)	0.31 [0.10, 0.96]