Table 2 Efficacy of Rotarix™ against severe rotavirus gastroenteritis by rotavirus P-types in South Africa and Malawi (according to protocol cohort for efficacy)
Rotarix™pooled group | Placebo | Vaccine efficacy% (95% CI) | p-value | ||||
|---|---|---|---|---|---|---|---|
N (n) | % (95%CI) | N (n) | % (95%CI) | ||||
Overall efficacy | 2974 (56) | 1.9 (1.4; 2.4) | 1443 (70) | 4.9 (3.8; 6.1) | 61.2 (44.0; 73.2) | <0.001 | |
Rotavirus type | |||||||
P4 | Overall | 2974 (12) | 0.4 (0.2; 0.7) | 1443 (20) | 1.4 (0.8; 2.1) | 70.9 (37.5; 87.0) | <0.001 |
South Africa | 1944 (1) | 0.1 (0.0; 0.3) | 960 (9) | 0.9 (0.4; 1.8) | 94.5 (60.4; 99.9) | 0.0003 | |
Malawi | 1030 (11) | 1.1 (0.5; 1.9) | 483 (11) | 2.3 (1.1; 4.0) | 53.1 (−19.3; 81.6) | 0.1036 | |
P6 | Overall | 2974 (12) | 0.4 (0.2; 0.7) | 1443 (13) | 0.9 (0.5; 1.5) | 55.2 (−6.5; 81.3) | 0.052 |
South Africa | 1944 (1) | 0.1 (0.0; 0.3) | 960 (2) | 0.2 (0.0; 0.8) | 75.3 (−374.3; 99.6) | 0.2555 | |
Malawi | 1030 (11) | 1.1 (0.5; 1.9) | 483 (11) | 2.3 (1.1; 4.0) | 53.1 (−19.3; 81.6) | 0.1036 | |
P8 | Overall | 2974 (32) | 1.1 (0.7; 1.5) | 1443 (38) | 2.6 (1.9; 3.6) | 59.1 (32.8; 75.3) | <0.001 |
South Africa | 1944 (13) | 0.7 (0.4; 1.1) | 960 (22) | 2.3 (1.4;, 3.4) | 70.8 (39.5; 86.5) | 0.0004 | |
Malawi | 1030 (19) | 1.8 (1.1; 2.9) | 483 (16) | 3.3 (1.9; 5.3) | 44.3 (−15.8; 72.9) | 0.0973 | |