Table 3. Total effectiveness of human rotavirus vaccine in preventing presentations of acute rotavirus diarrhea of any severity and severe acute rotavirus diarrhea among vaccinees, by age of onset and rotavirus strain detected.
| ARD analysis | HRV villages | Non-HRV villages | Adjusted VETc, percent (95% CI) | Adjusted rate differenced, percent (95% CI) | ||||
|---|---|---|---|---|---|---|---|---|
| Cases (n) | Person-yearsa | Incidence rateb | Cases (n) | Person-yearsa | Incidence rateb | |||
| VET (mITT) | ||||||||
| Any severity, all ages | 108 | 4,735 | 2.28 | 194 | 4,998 | 3.88 | 38.7 (20.6, 52.7) | 1.39 (0.47, 2.32) |
| VET (ATP) | ||||||||
| Any severity, all ages | 102 | 4,117 | 2.48 | 172 | 3,893 | 4.42 | 41.4 (23.2, 55.2) | 1.73 (0.64, 2.81) |
| Onset <12 mo | 75 | 2,464 | 3.04 | 135 | 2,340 | 5.77 | 45.2 (26.3, 59.3) | 2.61 (1.10, 4.12) |
| Onset 12–23 mo | 27 | 1,652 | 1.63 | 37 | 1,553 | 2.38 | 28.9 (−15.6, 56.3) | 0.36 (−0.89, 1.62) |
| G1P[8] | 18 | 4,166 | 0.43 | 38 | 3,984 | 0.95 | 54.5 (18.7, 74.6) | — |
| G2P[4] | 10 | 4,166 | 0.24 | 17 | 3,988 | 0.43 | 45.8 (−42.4, 79.4) | — |
| G9P[8] | 15 | 4,166 | 0.36 | 19 | 3,991 | 0.48 | 20.0 (−44.7, 55.8) | — |
| G12P[6] | 10 | 4,167 | 0.24 | 16 | 3,987 | 0.40 | 36.4 (−39.3, 71.1) | — |
| G12P[8] | 24 | 4,164 | 0.58 | 52 | 3,978 | 1.31 | 51.5 (18.5, 71.1) | — |
| Homotypic strain, all agese | 57 | 4,147 | 1.37 | 111 | 3,950 | 2.81 | 48.1 (27.9, 62.7) | — |
| Heterotypic strain, all agese | 20 | 4,159 | 0.48 | 34 | 3,973 | 0.86 | 43.0 (−2.9, 68.4) | — |
| Severef, all ages | 75 | 4,135 | 1.81 | 130 | 3,919 | 3.32 | 42.8 (22.1, 57.9) | 1.38 (0.42, 2.35) |
| Onset <12 mo | 53 | 2,472 | 2.14 | 101 | 2,351 | 4.30 | 48.0 (27.0, 63.0) | 2.08 (0.75, 3.41) |
| Onset 12–23 mo | 22 | 1,664 | 1.32 | 29 | 1,568 | 1.85 | 25.8 (−29.5, 57.5) | 0.36 (−0.80, 1.52) |
aPerson-time censored at first ARD episode.
bPer 100 person-years.
cEstimated using a Poisson regression model with a Pearson chi-squared scale parameter to account for clustering.
dEstimated per 100 person-years using the approach described in Section 12.3.2 of [21].
ePerson-time censored at first severe ARD episode, regardless of severity of previous ARD.
fHomotypic includes fully (G1P1A[8]) or partially (G1P# or G#P1A[8]) homotypic strains, while heterotypic includes strains that are neither G1 nor P1A [8]. # indicates any G or P serotype/genotype.
ARD, acute rotavirus diarrhea; ATP, according-to-protocol; HRV, human rotavirus vaccine; mITT, modified intention-to-treat; VET, total vaccine effectiveness.