Table 2

Efficacy ofRotarix™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

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 significant difference.

Steele et al.

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

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