Table 4.
Summary of poliovirus types 2 and 3 immune response and reciprocal antibody titers by study arms, modified intention-to-treat population.
| Arm A | Arm B | Arm C | Arm D | |||||
|---|---|---|---|---|---|---|---|---|
| mOPV1 + fIPV6 | mOPV1 + fIPVIO | mOPV1 | bOPV | |||||
| (n = 301) | (n = 295) | (n = 298) | (n = 298) | |||||
| Type 2 | ||||||||
| One dose, 10 weeks | ||||||||
| Immune response | 6 | 2% (1–5%) | 0 | – | 1 | 0% (0–2%) | 4 | 1% (0–4%) |
| Reciprocal antibody titers | 25.54 | (19.16–49.79) | – | – | 56.89 | (56.89–56.89) | 119.0 | (53.98–226.3) |
| Two doses, 14 weeks | ||||||||
| Cumulative immune response | 6 | 2% (1–5%) | 25 | 9% (6–12%) | 1 | 0% (0–2%) | 11 | 4% (2–7%) |
| Reciprocal antibody titers | 11.31 | (9.58–11.31) | 22.63 | (14.22–28.44) | 22.63 | (22.63–22.63) | 28.44 | (20.31–67.88) |
| Three doses, 18 weeks | ||||||||
| Cumulative immune response | 24 | 8% (5–12%) | 32 | 11% (8–15%) | 10 | 3% (2–6%) | 22 | 7 (5–11%) |
| Reciprocal antibody titers | 22.63 | (14.22–71.11) | 12.77 | (9.00–24.08) | 18.00 | (14.22–49.78) | 16.11 | (11.31–22.63) |
| Type 3 | ||||||||
| One dose, 10 weeks | ||||||||
| Immune response | 10 | 3% (2–6%) | 1 | 0% (0–2%) | 4 | 1% (0–4%) | 236 | 79% (74–84%) |
| Reciprocal antibody titers | 1152 | (629.3-≥1448) | 910.2 | (910.2–910.2) | 938.1 | (571.5–1226) | 1152 | (576.0-≥1448) |
| Two doses, 14 weeks | ||||||||
| Cumulative immune response | 17 | 6% (3–9%) | 15 | 5% (3–8%) | 8 | 3% (1–5%) | 273 | 92% (88–94%) |
| Reciprocal antibody titers | 724.1 | (288.0-≥1448) | 910.2 | (32.22-≥1448) | 650.1 | (343.5-≥1448) | 1152 | (576.0-≥1448) |
| Three doses, 18 weeks | ||||||||
| Cumulative immune response | 28 | 9% (6–13%) | 22 | 8% (5–11%) | 18 | 6% (4–10%) | 285 | 96% (93–98%) |
| Reciprocal antibody titers | 743.1 | (181.0-≥1448) | 910.2 | (30.33-≥1448) | 376.1 | (76.63–1152) | 1024 | (455.1-≥1448) |
Data are the percentage of participants with immune response expressed as n/N and percentage including 95% confidence interval (CI). Immune response defined as seroconversion from seronegative (<1:8) to seropositive (≥1:8), or a four-fold rise in antibody titers among seropositives adjusted for maternal antibody decay, and seropositivity maintained through 18 weeks of age. Cumulative immune response was defined as immune response at any point up to and including at the time of assessment. Reciprocal antibody titers are presented as the median (interquartile range) among responders. mOPV1 = monovalent oral poliovirus vaccine type 1. fIPV = fractional inactivated poliovirus vaccine. bOPV = bivalent oral poliovirus vaccine.