Table 3.
Seroconversion Rates 2 Weeks Following the Second Vaccination (Per Protocol Set).
| Sampling Time Point |
Lot Group 1 (N = 327) |
Lot Group 2 (N = 331) |
Lot Group 3 (N = 330) |
|---|---|---|---|
| Neutralizing Antibodies (Assessed by PRNT), n | 326 | 331 | 330 |
| Seroconversion, n (%) | 325 (99.7) | 328 (99.1) | 327 (99.1) |
| 95 % CI [LCL, UCL] | [98.3, 100.0] | [97.4, 99.8] | [97.4, 99.8] |
| p-valuea | 0.7102 | ||
| Total Antibodies (Assessed by ELISA), n | 326 | 331 | 330 |
| Seroconversion, n (%) | 323 (99.1) | 325 (98.2) | 326 (98.8) |
| 95 % CI [LCL, UCL] | [97.3, 99.8] | [96.1, 99.3] | [96.9, 99.7] |
| p-valuea | 0.6916 | ||
Abbreviations: CI = Confidence Interval; ELISA = Enzyme-linked Immunosorbent Assay; LCL = Lower Confidence Limit; LLOQ = Lower Limit of Quantitation; N = number of subjects in the specified group; n = number of subjects with available titer values; PRNT = Plaque Reduction Neutralization Test; UCL = Upper Confidence Limit.
Seroconversion was defined as either the appearance of antibody titers ≥ LLOQ for subjects with a titer below LLOQ at baseline, or a doubling (or more) of the antibody titer compared to the baseline titer for subjects with a titer equal or above the LLOQ at baseline.
The LLOQ for PRNT was 20 and 200 for ELISA.
95% CI: Clopper-Pearson 95% 2-sided confidence intervals for the proportion of seroconverted subjects.
Comparison of Lot Groups 1 to 3 using Freeman-Halton exact test.