| 1 Rotavirus diarrhoea: severe (up to 1 year follow‐up) |
9 |
10048 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.31 [0.22, 0.44] |
| 1.1 Low‐mortality countries (WHO strata A & B) |
5 |
4132 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.08 [0.03, 0.22] |
| 1.2 High‐mortality countries (WHO strata D & E) |
4 |
5916 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.43 [0.29, 0.62] |
| 2 Rotavirus diarrhoea: severe (up to 2 years follow‐up) |
8 |
13203 |
Risk Ratio (M‐H, Random, 95% CI) |
0.37 [0.23, 0.60] |
| 2.1 Low‐mortality countries (WHO strata A & B) |
4 |
7318 |
Risk Ratio (M‐H, Random, 95% CI) |
0.18 [0.08, 0.39] |
| 2.2 High‐mortality countries (WHO strata D & E) |
4 |
5885 |
Risk Ratio (M‐H, Random, 95% CI) |
0.59 [0.43, 0.82] |
| 3 All‐cause diarrhoea: severe cases (up to 1 year follow‐up) |
3 |
4085 |
Risk Ratio (M‐H, Random, 95% CI) |
0.80 [0.58, 1.11] |
| 3.1 Low‐mortality countries (WHO stratum A) |
0 |
0 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
| 3.2 High‐mortality countries (WHO strata D & E) |
3 |
4085 |
Risk Ratio (M‐H, Random, 95% CI) |
0.80 [0.58, 1.11] |
| 4 All‐cause diarrhoea: severe cases (up to 2 years follow‐up) |
4 |
5977 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.85 [0.75, 0.98] |
| 4.1 Low‐mortality countries (WHO strata A & B) |
0 |
0 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 4.2 High‐mortality countries (WHO strata D & E) |
4 |
5977 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.85 [0.75, 0.98] |
| 5 All‐cause death |
14 |
84448 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.96 [0.74, 1.25] |
| 5.1 Low‐mortality countries (WHO strata A & B) |
9 |
77642 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.13 [0.65, 1.96] |
| 5.2 High‐mortality countries (WHO strata D & E) |
5 |
6806 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.92 [0.68, 1.24] |
| 6 All serious adverse events |
14 |
82502 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.93 [0.86, 1.01] |
| 6.1 Low‐mortality countries (WHO strata A & B) |
8 |
75672 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.93 [0.86, 1.02] |
| 6.2 High‐mortality countries (WHO strata D & E) |
6 |
6830 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.92 [0.66, 1.28] |
| 7 Serious adverse events: intussusception |
16 |
85495 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.77 [0.41, 1.45] |
| 7.1 Low‐mortality countries (WHO strata A & B) |
12 |
78907 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.77 [0.41, 1.45] |
| 7.2 High‐mortality countries (WHO strata D & E) |
4 |
6588 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 8 Rotavirus diarrhoea: of any severity (up to 1 year follow‐up) |
8 |
13450 |
Risk Ratio (M‐H, Random, 95% CI) |
0.37 [0.28, 0.50] |
| 8.1 Low‐mortality countries (WHO strata A & B) |
5 |
8644 |
Risk Ratio (M‐H, Random, 95% CI) |
0.30 [0.25, 0.37] |
| 8.2 High‐mortality countries (WHO strata D & E) |
3 |
4806 |
Risk Ratio (M‐H, Random, 95% CI) |
0.52 [0.28, 0.94] |
| 9 Rotavirus diarrhoea: of any severity (up to 2 years follow‐up) |
7 |
12888 |
Risk Ratio (M‐H, Random, 95% CI) |
0.46 [0.33, 0.65] |
| 9.1 Low‐mortality countries (WHO strata A & B) |
3 |
6144 |
Risk Ratio (M‐H, Random, 95% CI) |
0.34 [0.26, 0.43] |
| 9.2 High‐mortality countries (WHO strata D & E) |
4 |
6744 |
Risk Ratio (M‐H, Random, 95% CI) |
0.61 [0.45, 0.83] |
| 10 All‐cause diarrhoea: of any severity (up to 1 year follow‐up) |
1 |
1059 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.82 [0.61, 1.11] |
| 10.1 Low‐mortality countries (WHO strata A & B) |
0 |
0 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 10.2 High‐mortality countries (WHO stratum E) |
1 |
1059 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.82 [0.61, 1.11] |
| 11 All‐cause diarrhoea: of any severity (up to 2 years follow‐up) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 11.1 High‐mortality countries (WHO stratum E) |
1 |
1059 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.89 [0.68, 1.16] |
| 12 All‐cause hospitalizations (up to 2 years follow‐up) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
| 12.1 High‐mortality countries (WHO strata D & E) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 13 Rotavirus diarrhoea: requiring hospitalization |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
| 13.1 Up to 1 year of follow‐up |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 14 Rotavirus diarrhoea: requiring medical attention |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
| 14.1 Up to 1 year of follow‐up |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 15 Reactogenicity: fever |
12 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 15.1 After dose 1 |
4 |
7124 |
Risk Ratio (M‐H, Random, 95% CI) |
1.15 [0.91, 1.45] |
| 15.2 After dose 2 |
2 |
4322 |
Risk Ratio (M‐H, Random, 95% CI) |
0.83 [0.69, 1.01] |
| 15.3 After dose 3 |
2 |
4294 |
Risk Ratio (M‐H, Random, 95% CI) |
1.07 [0.90, 1.27] |
| 15.4 End of follow‐up |
11 |
18391 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.94, 1.09] |
| 16 Reactogenicity: diarrhoea |
10 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 16.1 After dose 1 |
2 |
4745 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.12 [0.95, 1.32] |
| 16.2 After dose 2 |
1 |
3905 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.89 [0.72, 1.10] |
| 16.3 End of follow‐up |
10 |
17087 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.98, 1.10] |
| 17 Reactogenicity: vomiting |
9 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 17.1 After dose 1 |
2 |
4745 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.84 [0.63, 1.12] |
| 17.2 After dose 2 |
1 |
3905 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.69 [0.32, 1.49] |
| 17.3 After dose 3 |
1 |
3878 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.46 [0.16, 1.32] |
| 17.4 End of follow‐up |
9 |
16294 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.98 [0.90, 1.06] |
| 18 Adverse events requiring discontinuation (end of follow‐up) |
10 |
15471 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.89 [0.57, 1.39] |
| 19 Immunogenicity: rotavirus vaccine shedding (after dose 3) |
5 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Totals not selected |
| 20 Immunogenicity: seroconversion |
10 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Totals not selected |
| 20.1 After dose 3 |
10 |
|
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
| 21 Dropouts before the end of the trial |
13 |
85855 |
Risk Ratio (M‐H, Random, 95% CI) |
0.98 [0.90, 1.08] |
| 22 Subgroup analysis: rotavirus diarrhoea of any severity (by G type) |
4 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 22.1 G1 |
4 |
11022 |
Risk Ratio (M‐H, Random, 95% CI) |
0.26 [0.21, 0.32] |
| 22.2 G2 |
3 |
9907 |
Risk Ratio (M‐H, Random, 95% CI) |
0.35 [0.16, 0.78] |
| 22.3 G3 |
4 |
11022 |
Risk Ratio (M‐H, Random, 95% CI) |
0.40 [0.08, 2.02] |
| 22.4 G4 |
3 |
9907 |
Risk Ratio (M‐H, Random, 95% CI) |
0.41 [0.13, 1.33] |
| 22.5 G9 |
2 |
9537 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.20, 0.54] |
| 23 Subgroup analysis: severe cases of rotavirus diarrhoea (by G type) |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 23.1 G1 |
3 |
76606 |
Risk Ratio (M‐H, Random, 95% CI) |
0.23 [0.03, 1.74] |
| 23.2 G2 |
3 |
76606 |
Risk Ratio (M‐H, Random, 95% CI) |
0.41 [0.13, 1.37] |
| 23.3 G3 |
3 |
76606 |
Risk Ratio (M‐H, Random, 95% CI) |
0.38 [0.05, 2.74] |
| 23.4 G4 |
3 |
76606 |
Risk Ratio (M‐H, Random, 95% CI) |
0.12 [0.03, 0.46] |
| 23.5 G9 |
3 |
76606 |
Risk Ratio (M‐H, Random, 95% CI) |
0.13 [0.05, 0.34] |
| 24 Subgroup analysis: HIV‐infected children |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 24.1 Rotavirus diarrhoea: severe (up to two years follow‐up) |
1 |
38 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.45 [0.11, 56.68] |
| 24.2 All‐cause diarrhoea: severe (up to two years follow‐up) |
1 |
38 |
Risk Ratio (M‐H, Fixed, 95% CI) |
4.05 [0.52, 31.43] |
| 24.3 All‐cause death |
2 |
114 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.29 [0.51, 3.21] |
| 24.4 Serious adverse events (up to 24 weeks) |
2 |
113 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.53 [0.59, 3.97] |
