Table 2.
Antibody Titers and Ratios Between Groups at 2 Weeks After the Second Vaccination (Per Protocol Set).
|
Lot Group 1 (N = 327) |
Lot Group 2 (N = 331) |
Lot Group 3 (N = 330) |
|
|---|---|---|---|
| Neutralizing Antibodies (Assessed by PRNT) | |||
| Baseline, n | 326 | 331 | 330 |
| <LLOQ, n (%) | 321 (98.5) | 322 (97.3) | 322 (97.6) |
| 2 Weeks After Second Vaccination (Visit 4), n | 327 | 331 | 330 |
| GMT | 252.7 | 269.9 | 242.0 |
| 95 % CI [LCL, UCL] | [231.3, 276.0] | [243.2, 299.7] | [219.5, 266.8] |
| GMT Ratio Compared to Group 3 | 1.044 | 1.115 | |
| 95 % CI [LCL, UCL] | [0.915, 1.191] | [0.967, 1.287] | |
| Equivalence Meta | Yes | Yes | |
| GMT Ratio Compared to Group 2 | 0.936 | ||
| 95 % CI [LCL, UCL] | [0.816, 1.073] | ||
| Equivalence Met a | Yes | ||
| Total Antibodies (Assessed by ELISA) | |||
| Baseline, n | 326 | 331 | 330 |
| <LLOQ, n (%) | 324 (99.4) | 329 (99.4) | 329 (99.7) |
| 2 Weeks After Second Vaccination (Visit 4), n | 327 | 331 | 330 |
| GMT | 1222.0 | 1311.0 | 1226.1 |
| 95 % CI [LCL, UCL] | [1123.3, 1329.4] | [1195.7, 1437.5] | [1118.1, 1344.6] |
| GMT Ratio compared to Group 3 | 0.997 | 1.069 | |
| 95 % CI [LCL, UCL] | [0.880, 1.129] | [0.939, 1.218] | |
| GMT Ratio compared to Group 2 | 0.932 | ||
| 95 % CI [LCL, UCL] | [0.823, 1.056] | ||
Abbreviations: CI = Confidence Interval; ELISA = Enzyme-linked Immunosorbent Assay; LCL = Lower Confidence Limit; LLOQ = Lower Limit of Quantitation; N = number of subjects in the PPS in the specified group; n = number of subjects with available titer values; PRNT = Plaque Reduction Neutralization Test; UCL = Upper Confidence Limit.
Note: Geometric means were calculated using the mean of the log10 transformed titer values, with corresponding 95% CIs based on a t-test.
Note: Antibody titers below the LLOQ were given a value of half of the LLOQ. The LLOQ was 20 for PRNT and 200 for ELISA.
Equivalence (only assessed for neutralizing antibodies) was met if the LCL > 1/2 and UCL < 2 for PRNT.