Table 1

Efficacy ofRotarix™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

N = number of infants included in each group.

n = number of infants reporting at least one event in each group.

% = percentage of infants reporting at least one event.

95% CI = 95% Confidence interval.

P-value = Two-sided Fisher Exact test; p-values < 0.05 indicate statistically significantdifference.

Steele et al.

Steele et al. BMC Infectious Diseases 2012 12:213   doi:10.1186/1471-2334-12-213

Open Data