Table 2.
Case Counts and Relative Incidence of Confirmed Intussusception Cases after ROTAVAC® Vaccination in Indian Infants.a
| Doses of Rotavirus vaccines | Risk period | No. of BL1 cases | RI (95% CI) in the risk periodb |
|---|---|---|---|
| Primary Analysis | |||
| Combined dose (1 + 2)c | 1–21 | 3 | 1.56 (0.0–5.28) |
| Secondary Analysis | |||
| Dose-1 | 1–21 | 1 | 1.75 (0.0–7.80) |
| Dose-2 | 1–21 | 2 | 1.51 (0.0–5.58) |
| Dose-3 | 1–21 | 10 | 2.02 (0.74–4.88) |
| Combined all doses | 1–21 | 13 | 1.88 (0.76–4.30) |
| Combined Dose (1 + 2) | 1–7 | 0 | – |
| Combined Dose (1 + 2) | 8–21 | 3 | 2.00 (0.0–6.44) |
| Dose-3 | 1–7 | 1 | 0.71 (0.0–3.25) |
| Dose-3 | 8–21 | 9 | 2.36 (0.73–5.23) |
| Dose-1 | 1–7 | 0 | – |
| Dose-1 | 8–21 | 1 | 2.26 (0.0–8.87) |
| Dose-2 | 1–7 | 0 | – |
| Dose-2 | 8–21 | 2 | 1.92 (0.0–6.79) |
| Dose-3 | 1–7 | 1 | 0.71 (0.0–3.23) |
| Dose-3 | 8–21 | 9 | 2.36 (0.74–5.20) |
| Combined all doses | 1–7 | 1 | 0.51 (0.0–2.38) |
| Combined all doses | 8–21 | 12 | 2.16 (0.89–4.46) |
| Sensitivity analysis (including BL2 cases) | |||
| Combined Dose-1 + 2c | 1–21 | 3 | 1.20 (0.0–4.18) |
| Dose-1 | 1–21 | 1 | 0.96 (0.0–5.25) |
| Dose-2 | 1–21 | 2 | 1.30 (0.0–4.91) |
| Dose-3 | 1–21 | 10 | 1.65 (0.65–3.84) |
| Combined all doses | 1–21 | 13 | 1.51 (0.58–3.23) |
BL1 = Brighton Level 1; BL2 = Brighton Level 2.
a
Intussusception cases in the control periods: (a) after 21 days of first dose and before second dose = 7; (b) after 21 days of second dose and before third dose = 7; (c) intussusception cases after 21 days of the third dose till age of 365 days = 77.
b
95% CI generated via bootstrapping with 1000 iterations.
c
After adjusting for the risk in the post-dose 3 period.