Table 3.
Stool poliovirus shedding index endpoint
| Candidate 1 (n=15) | Candidate 2 (n=15) | |
|---|---|---|
| Day 7 | ||
| Number of stool samples | 14 | 11 |
| Number of participants shedding (%) | 14 (100%) | 8 (73%) |
| Median log10(CCID50/g) (95% CI) | 4·1 (3·8–4·5) | 3·3 (0·0–3·7) |
| Median log10(CCID50/g) among those shedding (95% CI) | 4·1 (3·8–4·5) | 3·4 (2·9–3·8) |
| Day 14 | ||
| Number of stool samples | 13 | 13 |
| Number of participants shedding (%) | 10 (77%) | 3 (23%) |
| Median log10(CCID50/g) (95% CI) | 2·9 (2·8–3·3) | 0·0 (0·0–0·0) |
| Median log10(CCID50/g) among those shedding (95% CI) | 3·1 (2·9–3·6) | 2·9 (2·8–4·0) |
| Day 21 | ||
| Number of stool samples | 14 | 13 |
| Number of participants shedding (%) | 9 (64%) | 3 (23%) |
| Median log10(CCID50/g) (95% CI) | 2·9 (0·0–3·3) | 0·0 (0·0–0·0) |
| Median log10(CCID50/g) among those shedding (95% CI) | 3·0 (2·8–3·4) | 3·2 (3·1–3·9) |
| Day 28 | ||
| Number of stool samples | 11 | 8 |
| Number of participants shedding (%) | 5 (46%) | 3 (38%) |
| Median log10(CCID50/g) (95% CI) | 0·0 (0·0–2·9) | 0·0 (0·0–3·2) |
| Median log10(CCID50/g) among those shedding (95% CI) | 2·9 (2·8–3·7) | 3·2 (3·0–4·1) |
| Shedding index endpoint (days 7, 14, 21, and 28) | ||
| Number of stool samples | 15 | 15 |
| Median shedding index (95% CI) | 2·8 (1·8–3·5) | 1·0 (0·7–1·6) |
| Median shedding index among those shedding (95% CI) | 2·8 (1·8–3·5) | 1·3 (0·9–2·0) |
The viral shedding index endpoint was calculated as the mean log10(CCID50/g) over days 7, 14, 21, and 28, with the lower limit of quantitation (2·75 log10) as an observed value and all titres in stool samples with negative shedding results set to zero. CIs were obtained via the percentile bootstrap method. If a titre was missing at days 7, 14, 21, or 28, it was replaced by a neighbouring value. If both neighbouring values were available, the titre was replaced by the mean of these values. The median shedding index among those shedding was calculated by excluding subjects that were PCR-negative for shedding at all timepoints. CCID50=50% cell culture infectious dose.