Table 8.
Percentage of participants with vaccine-virus rotavirus strain in stool samples collected at combined pre-determined time points – infant cohort (ATP).
| |
Vaccine-virus Rotavirus Shedding at Combined Time Points |
||||
|---|---|---|---|---|---|
| 95% CI |
|||||
| Dose | Group | N | n (%) | LL (%) | UL (%) |
| Dose 1 | HSRV vaccine | 25 | 0 | 0 | 13.72 |
| RotaTeq® | 25 | 2 (8.0) | 0.98 | 26.0 | |
| Dose 2 | HSRV vaccine | 25 | 0 | 0 | 13.72 |
| RotaTeq® | 25 | 0 | 0 | 13.72 | |
| Dose 3 | HSRV vaccine | 25 | 0 | 0 | 13.72 |
| RotaTeq® | 25 | 0 | 0 | 13.72 | |
Abbreviations: N: Total number of participants in the treatment arm with an evaluable stool sample at that time point.
Abbreviations: 95% CI = Clopper–Pearson 95% confidence interval; HSRV = Heat-stable rotavirus vaccine; LL = Lower limit; N = Number of participants dosed in the treatment arm; n = Number of participants with Vaccine-Rotavirus strain in stool samples; UL = Upper limit.
% was calculated using the total number of participants in the treatment arm as the denominator (n/N)*100.