| 1 Rotavirus diarrhoea: severe (up to 1 year follow‐up) |
11 |
49893 |
Risk Ratio (M‐H, Random, 95% CI) |
0.22 [0.14, 0.34] |
| 1.1 Low‐mortality countries (WHO strata A & B) |
7 |
43779 |
Risk Ratio (M‐H, Random, 95% CI) |
0.16 [0.09, 0.26] |
| 1.2 High‐mortality countries (WHO strata D & E) |
4 |
6114 |
Risk Ratio (M‐H, Random, 95% CI) |
0.37 [0.23, 0.60] |
| 2 Rotavirus diarrhoea: severe (up to 2 years follow‐up) |
12 |
|
Risk Ratio (Fixed, 95% CI) |
0.34 [0.29, 0.41] |
| 2.1 Low‐mortality countries (WHO strata A & B) |
9 |
|
Risk Ratio (Fixed, 95% CI) |
0.18 [0.14, 0.23] |
| 2.2 High‐mortality countries (WHO strata D & E) |
3 |
|
Risk Ratio (Fixed, 95% CI) |
0.65 [0.51, 0.83] |
| 3 All‐cause diarrhoea: severe cases (up to 1 year follow‐up) |
6 |
33690 |
Risk Ratio (M‐H, Random, 95% CI) |
0.66 [0.54, 0.80] |
| 3.1 Low‐mortality countries (WHO strata A & B) |
3 |
28051 |
Risk Ratio (M‐H, Random, 95% CI) |
0.59 [0.47, 0.74] |
| 3.2 High‐mortality countries (WHO strata D & E) |
3 |
5639 |
Risk Ratio (M‐H, Random, 95% CI) |
0.73 [0.56, 0.95] |
| 4 All‐cause diarrhoea: severe cases (up to 2 years follow‐up) |
5 |
12181 |
Risk Ratio (M‐H, Random, 95% CI) |
0.70 [0.54, 0.92] |
| 4.1 Low‐mortality countries (WHO strata A & B) |
3 |
9417 |
Risk Ratio (M‐H, Random, 95% CI) |
0.60 [0.36, 1.02] |
| 4.2 High‐mortality countries (WHO strata D & E) |
2 |
2764 |
Risk Ratio (M‐H, Random, 95% CI) |
0.83 [0.72, 0.96] |
| 5 All‐cause diarrhoea: severe episodes (up to 1 year follow‐up) |
1 |
|
Rate Ratio (Fixed, 95% CI) |
Totals not selected |
| 5.1 Low‐mortality countries (WHO strata A & B) |
1 |
|
Rate Ratio (Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 6 All‐cause diarrhoea: severe episodes (up to 2 years follow‐up) |
2 |
|
Rate Ratio (Fixed, 95% CI) |
Subtotals only |
| 6.1 Low‐mortality countries (WHO strata A & B) |
2 |
|
Rate Ratio (Fixed, 95% CI) |
0.63 [0.56, 0.71] |
| 7 All‐cause death |
30 |
105778 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.03 [0.82, 1.30] |
| 7.1 Low‐mortality countries (WHO strata A & B) |
22 |
97597 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.22 [0.87, 1.71] |
| 7.2 High‐mortality countries (WHO strata D & E) |
8 |
8181 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.88 [0.64, 1.22] |
| 8 All serious adverse events |
31 |
103714 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.88 [0.83, 0.93] |
| 8.1 Low‐mortality countries (WHO strata A & B) |
24 |
96233 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.88 [0.83, 0.93] |
| 8.2 High‐mortality countries (WHO strata D & E) |
7 |
7481 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.89 [0.76, 1.04] |
| 9 Serious adverse events: intussusception |
21 |
|
Risk Ratio (Fixed, 95% CI) |
0.70 [0.46, 1.05] |
| 9.1 Low‐mortality countries (WHO strata A & B) |
17 |
|
Risk Ratio (Fixed, 95% CI) |
0.69 [0.45, 1.04] |
| 9.2 High‐mortality countries (WHO stratum E) |
4 |
|
Risk Ratio (Fixed, 95% CI) |
1.49 [0.06, 36.63] |
| 10 Serious adverse events: Kawasaki disease |
3 |
13117 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.79 [0.30, 10.61] |
| 11 Serious adverse events requiring hospitalization |
2 |
63675 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.88 [0.81, 0.96] |
| 12 Rotavirus diarrhoea: of any severity (up to 2 months follow‐up) |
12 |
4294 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.17 [0.69, 2.00] |
| 12.1 Low‐mortality countries (WHO strata A & B) |
9 |
3537 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.28 [0.66, 2.50] |
| 12.2 High‐mortality countries (WHO strata D & E) |
3 |
757 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.0 [0.41, 2.41] |
| 13 Rotavirus diarrhoea: of any severity (up to 1 year follow‐up) |
8 |
15197 |
Risk Ratio (M‐H, Random, 95% CI) |
0.34 [0.23, 0.50] |
| 13.1 Low‐mortality countries (WHO strata A & B) |
4 |
9083 |
Risk Ratio (M‐H, Random, 95% CI) |
0.22 [0.13, 0.40] |
| 13.2 High‐mortality countries (WHO stratum E) |
4 |
6114 |
Risk Ratio (M‐H, Random, 95% CI) |
0.49 [0.35, 0.68] |
| 14 Rotavirus diarrhoea: of any severity (up to 2 years follow‐up) |
7 |
11692 |
Risk Ratio (M‐H, Random, 95% CI) |
0.36 [0.28, 0.47] |
| 14.1 Low‐mortality countries (WHO strata A & B) |
6 |
10441 |
Risk Ratio (M‐H, Random, 95% CI) |
0.35 [0.25, 0.48] |
| 14.2 High‐mortality countries (WHO stratum E) |
1 |
1251 |
Risk Ratio (M‐H, Random, 95% CI) |
0.41 [0.28, 0.62] |
| 15 All‐cause diarrhoea: all cases (up to 2 months follow‐up) |
7 |
3132 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.89 [0.72, 1.10] |
| 15.1 Low‐mortality countries (WHO strata A & B) |
6 |
3032 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.86 [0.67, 1.09] |
| 15.2 High‐mortality countries (WHO stratum E) |
1 |
100 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.69, 1.58] |
| 16 All‐cause diarrhoea: all cases (up to 1 year follow‐up) |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 16.1 Low‐mortality countries (WHO strata A & B) |
2 |
2204 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.92 [0.82, 1.03] |
| 16.2 High‐mortality countries (WHO strata D & E) |
1 |
700 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.99 [0.93, 1.05] |
| 17 All‐cause diarrhoea: all cases (up to 2 years follow‐up) |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 17.1 Low‐mortality countries (WHO strata A & B) |
3 |
5937 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.93 [0.87, 1.00] |
| 18 All‐cause diarrhoea: all episodes (up to 1 year follow‐up) |
2 |
|
Rate Ratio (Fixed, 95% CI) |
Subtotals only |
| 18.1 Low‐mortality countries (WHO strata A & B) |
2 |
|
Rate Ratio (Fixed, 95% CI) |
0.98 [0.88, 1.10] |
| 19 All‐cause diarrhoea: all episodes (up to 2 years follow‐up) |
1 |
|
Rate Ratio (Fixed, 95% CI) |
Totals not selected |
| 19.1 Low‐mortality countries (WHO strata A & B) |
1 |
|
Rate Ratio (Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 20 All‐cause hospitalizations (up to 2 years follow‐up) |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 20.1 Low‐mortality countries (WHO strata A & B) |
2 |
65646 |
Risk Ratio (M‐H, Random, 95% CI) |
0.63 [0.27, 1.47] |
| 21 Rotavirus diarrhoea: requiring hospitalization |
11 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 21.1 Up to 1 year follow‐up (at least 1 rotavirus season) |
8 |
48718 |
Risk Ratio (M‐H, Random, 95% CI) |
0.18 [0.09, 0.33] |
| 21.2 Second year follow‐up (at least 2 rotavirus seasons) |
7 |
35331 |
Risk Ratio (M‐H, Random, 95% CI) |
0.15 [0.11, 0.22] |
| 22 Rotavirus diarrhoea: requiring medical attention |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 22.1 Up to 1 year follow‐up (at least 1 rotavirus season) |
1 |
3874 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.08 [0.04, 0.16] |
| 22.2 Second year follow‐up (at least 2 rotavirus seasons) |
3 |
7017 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.22 [0.16, 0.31] |
| 23 All‐cause diarrhoea: cases requiring hospitalization |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 23.1 Up to one year of follow‐up (at least 1 rotavirus season) |
2 |
14393 |
Risk Ratio (M‐H, Random, 95% CI) |
0.43 [0.17, 1.11] |
| 23.2 Second year of follow‐up (at least 2 rotavirus seasons) |
2 |
14367 |
Risk Ratio (M‐H, Random, 95% CI) |
0.52 [0.27, 0.99] |
| 24 All‐cause diarrhoea: episodes requiring hospitalization |
1 |
|
Rate Ratio (Fixed, 95% CI) |
Subtotals only |
| 24.1 Up to 1 year of follow‐up (at least 1 rotavirus season) |
1 |
|
Rate Ratio (Fixed, 95% CI) |
0.58 [0.47, 0.71] |
| 24.2 Second year of follow‐up (at least 2 rotavirus seasons) |
1 |
|
Rate Ratio (Fixed, 95% CI) |
0.53 [0.46, 0.61] |
| 25 Reactogenicity: fever |
28 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 25.1 After dose 1 |
25 |
16192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.06 [0.97, 1.17] |
| 25.2 After dose 2 |
24 |
15630 |
Risk Ratio (M‐H, Random, 95% CI) |
0.99 [0.92, 1.06] |
| 25.3 After dose 3 |
4 |
1390 |
Risk Ratio (M‐H, Random, 95% CI) |
0.98 [0.86, 1.13] |
| 25.4 End of follow‐up |
18 |
11926 |
Risk Ratio (M‐H, Random, 95% CI) |
0.97 [0.93, 1.01] |
| 26 Reactogenicity: diarrhoea |
27 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 26.1 After dose 1 |
25 |
18732 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.88, 1.17] |
| 26.2 After dose 2 |
24 |
15630 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.86, 1.21] |
| 26.3 After dose 3 |
4 |
1390 |
Risk Ratio (M‐H, Random, 95% CI) |
0.69 [0.35, 1.36] |
| 26.4 End of follow‐up |
17 |
14305 |
Risk Ratio (M‐H, Random, 95% CI) |
0.95 [0.84, 1.08] |
| 27 Reactogenicity: vomiting |
27 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 27.1 After dose 1 |
25 |
18732 |
Risk Ratio (M‐H, Random, 95% CI) |
1.03 [0.94, 1.12] |
| 27.2 After dose 2 |
24 |
15630 |
Risk Ratio (M‐H, Random, 95% CI) |
0.92 [0.81, 1.05] |
| 27.3 After dose 3 |
4 |
1390 |
Risk Ratio (M‐H, Random, 95% CI) |
1.34 [0.71, 2.50] |
| 27.4 End of follow‐up |
17 |
14305 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.84, 1.04] |
| 28 Adverse events requiring discontinuation (end of follow‐up) |
26 |
94980 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.03 [0.83, 1.26] |
| 29 Immunogenicity: rotavirus vaccine shedding (end of follow‐up) |
16 |
2638 |
Risk Ratio (M‐H, Random, 95% CI) |
10.94 [4.90, 24.43] |
| 30 Immunogenicity: seroconversion |
31 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 30.1 After dose 1 |
9 |
2537 |
Risk Ratio (M‐H, Random, 95% CI) |
20.39 [8.48, 49.01] |
| 30.2 After dose 2 |
27 |
8742 |
Risk Ratio (M‐H, Random, 95% CI) |
11.44 [8.01, 16.32] |
| 30.3 After dose 3 |
5 |
1137 |
Risk Ratio (M‐H, Random, 95% CI) |
6.89 [3.59, 13.24] |
| 31 Dropouts before the end of the trial |
28 |
93106 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.95 [0.90, 1.00] |
| 32 Subgroup analysis: rotavirus diarrhoea of any severity (by G type) |
6 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 32.1 G1 |
6 |
27583 |
Risk Ratio (M‐H, Random, 95% CI) |
0.21 [0.10, 0.44] |
| 32.2 G2 |
5 |
26835 |
Risk Ratio (M‐H, Random, 95% CI) |
0.41 [0.31, 0.56] |
| 32.3 G3 |
4 |
8968 |
Risk Ratio (M‐H, Random, 95% CI) |
0.14 [0.05, 0.39] |
| 32.4 G4 |
2 |
5720 |
Risk Ratio (M‐H, Random, 95% CI) |
0.20 [0.07, 0.59] |
| 32.5 G9 |
3 |
8868 |
Risk Ratio (M‐H, Random, 95% CI) |
0.37 [0.18, 0.75] |
| 33 Subgroup analysis: severe cases of rotavirus diarrhoea (by G type) |
8 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 33.1 G1 |
7 |
39428 |
Risk Ratio (M‐H, Random, 95% CI) |
0.24 [0.16, 0.38] |
| 33.2 G2 |
7 |
44682 |
Risk Ratio (M‐H, Random, 95% CI) |
0.30 [0.18, 0.50] |
| 33.3 G3 |
5 |
20505 |
Risk Ratio (M‐H, Random, 95% CI) |
0.17 [0.05, 0.56] |
| 33.4 G4 |
1 |
2421 |
Risk Ratio (M‐H, Random, 95% CI) |
0.12 [0.00, 2.95] |
| 33.5 G8 |
2 |
4417 |
Risk Ratio (M‐H, Random, 95% CI) |
0.22 [0.02, 2.37] |
| 33.6 G9 |
6 |
26815 |
Risk Ratio (M‐H, Random, 95% CI) |
0.23 [0.13, 0.40] |
| 33.7 G12 |
2 |
4417 |
Risk Ratio (M‐H, Random, 95% CI) |
0.47 [0.23, 0.97] |
| 34 Subgroup analysis: rotavirus diarrhoea in malnourished children |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
| 34.1 Up to 1 year of follow‐up (at least 1 rotavirus season) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 35 Subgroup analysis: rotavirus diarrhoea in HIV‐infected children |
1 |
100 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.0 [0.26, 3.78] |
