Table 1 Efficacy of Rotarix™ against severe rotavirus gastroenteritis by rotavirus G-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 | |||||||
G1 wild-type | Overall | 2974 (17) | 0.6 (0.3; 0.9) | 1443 (23) | 1.6 (1.0; 2.4) | 64.1 (29.9; 82.0) | 0.002 |
South Africa | 1944 (11) | 0.6 (0.3; 1.0) | 960 (18) | 1.9 (1.1; 2.9) | 69.8 (32.5; 87.1) | 0.0022 | |
Malawi | 1030 (6) | 0.6 (0.2; 1.3) | 483 (5) | 1.0 (0.3; 2.4) | 43.7 (−133.1; 85.7) | 0.3427 | |
G2 | Overall | 2974 (3) | 0.1 (0.0; 0.3) | 1443 (7) | 0.5 (0.2; 1.0) | 79.2 (8.9; 96.5) | 0.017 |
South Africa | 1944 (1) | 0.1 (0.0; 0.3) | 960 (6) | 0.6 (0.2; 1.4) | 91.8 (32.2; 99.8) | 0.0065 | |
Malawi | 1030 (2) | 0.2 (0.0; 0.7) | 483 (1) | 0.2 (0.0; 1.1) | 6.2 (−5433.1; 95.1) | 1.0000 | |
G3 | Overall | 2974 (2) | 0.1 (0.0; 0.2) | 1443 (6) | 0.4 (0.2; 0.9) | 83.8 (9.6; 98.4) | 0.018 |
South Africa | 1944 (2) | 0.1 (0.0; 0.4) | 960 (6) | 0.6 (0.2; 1.4) | 83.5 (7.9; 98.4) | 0.0187 | |
Malawi | 1030 (0) | 0.0 (0.0; 0.4) | 483 (0) | 0.0 (0.0; 0.8) | – | – | |
G8 | Overall | 2974 (11) | 0.4 (0.2; 0.7) | 1443 (15) | 1.0 (0.6; 1.7) | 64.4 (17.1; 85.2) | 0.010 |
South Africa | 1944 (0) | 0.0 (0.0; 0.2) | 960 (5) | 0.5 (0.2; 1.2) | 100.0 (46.1; 100.0) | 0.0039 | |
Malawi | 1030 (11) | 1.1 (0.5; 1.9) | 483 (10) | 2.1 (1.0; 3.8) | 48.4 (−35.5; 80.1) | 0.1553 | |
G9 | Overall | 2974 (8) | 0.3 (0.1; 0.5) | 1443 (9) | 0.6 (0.3; 1.2) | 56.9 (−25.9; 85.5) | 0.116 |
South Africa | 1944 (0) | 0.0 (0.0;, 0.2) | 960 (0) | 0.0 (0.0; 0.4) | – | – | |
Malawi | 1030 (8) | 0.8 (0.3; 1.5) | 483 (9) | 1.9 (0.9; 3.5) | 58.3 (−21.7; 86.0) | 0.0702 | |
G12 | Overall | 2974 (15) | 0.5 (0.3; 0.8) | 1443 (15) | 1.0 (0.6; 1.7) | 51.5 (−6.5; 77.9) | 0.051 |
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 (14) | 1.4 (0.7; 2.3) | 483 (13) | 2.7 (1.4; 4.6) | 49.5 (−16.7; 78.0) | 0.0933 | |
Non-G1 | Overall | 2974 (39) | 1.3 (0.9; 1.8) | 1443 (47) | 3.3 (2.4; 4.3) | 59.7 (37.1; 74.4) | <0.001 |
South Africa | 1944 (4) | 0.2 (0.1; 0.5) | 960 (14) | 1.5 (0.8; 2.4) | 85.9 (55.1; 96.6) | 0.0001 | |
Malawi | 1030 (35) | 3.4 (2.4; 4.7) | 483 (33) | 6.8 (4.7; 9.5) | 50.3 (17.4; 70.0) | 0.0048 | |