Table 3.
Summary of poliovirus type 1 vaccine virus detected among participants by select study arms.
Vaccine virus shedding | Arm A | Arm B | Arm C | Arm D | Fisher’s Exact Test | ||||
---|---|---|---|---|---|---|---|---|---|
mOPV1 + fIPV6 |
mOPV1 + fIPV10 |
mOPV1 |
bOPV |
||||||
(n = 301) | (n = 295) | (n = 298) | (n = 298) | ||||||
Baseline*, 6 weeks | – | – | 4/294 | 1% (0–4%) | 6/297 | 2% (1–5%) | 6/296 | 2% (1–5%) | |
One week, 7 weeks | – | – | 253/290 | 87% (83–91%) | 240/291 | 83% (78–87%) | 233/290 | 80% (75–85%) | B/C v D: p = 0.10 |
Two weeks, 8 weeks | – | – | 234/290 | 81% (76–85%) | 209/291 | 72% (66–77%) | 162/290 | 56% (50–62%) | B/C v D: p < 0.0001 |
Baseline*, 14 weeks | 41/295 | 14% (10–19%) | 39/288 | 14% (10–18%) | 50/294 | 17% (13–22%) | – | – | |
One week, 15 weeks | 51/254 | 20% (15–26%) | 24/249 | 10% (6–14%) | 52/244 | 21% (17–27%) | A vs C: p = 0.74 B vs C: p = 0.0004 |
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Two weeks, 16 weeks | 25/254 | 10% (6–14%) | 14/249 | 6% (3–10%) | 35/244 | 14% (10–20%) | A v C: p = 0.13 B vs C: p = 0.0014 |
Data are the percentage of participants with vaccine virus detected in stool specimens expressed as n/N and percentage including 95% confidence interval (CI).
Restricted to participants who were not shedding at baseline (either 6 weeks or 14 weeks depending on objective) and had stool specimen results available one week and two weeks post-vaccination. mOPV1 = monovalent oral poliovirus vaccine type 1, fIPV = fractional inactivated poliovirus vaccine, bOPV = bivalent oral poliovirus vaccine. Fisher’s Exact test was used to test for inequality of proportions between study arms.