Table 1.
Co-primary endpoints (GMT and SRR) with GMTR and SRR difference in SARS-CoV-2 neutralizing antibody response on day 29, and GMT and SRR at baseline and on day 15.
| Outcome | BNT162b2 (n = 102) |
S-268019-b (n = 101) |
||||
|---|---|---|---|---|---|---|
| (95% CI) | Baseline | Day 15a | Day 29a | Baseline | Day 15 | Day 29 |
| GMTb | 6.65 (5.73, 7.72) | 139.48 (122.50, 158.82) | 109.70 (95.73, 125.70) | 5.47 (4.81, 6.21) | 127.57 (112.03, 145.28) | 124.97 (108.33, 144.18) |
| Adjusted-GMTRc | – | – | – | – | – | 1.14 (0.94, 1.39) |
| SRRd | – | 99.0 (94.6, 100.0) | 100.0 (96.4, 100.0) | – | 100.0 (96.4, 100.0) | 100.0 (96.4, 100.0) |
| SRR differenced | – | – | – | – | – | 0.0 (−5.9, 5.9) |
GMT, geometric mean titer; GMTR, geometric mean titer ratio; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SRR, seroresponse rate. Criteria for noninferiority confirmed when lower limit of 95% CI > 0.67 for GMTR (S-268019-b/BNT162b2) and >−10% for SRR difference (S-268019-b – BNT162b2).
On day 15 and day 29, BNT162b2 group had 101 participants. bThe GMTs with corresponding 95% CIs were estimated by back transformation from the arithmetic mean and the 95% CIs based on the Student’s t distribution of log-transformed titers to the original scale. cThe adjusted-GMTR and its 95% CI were obtained using analysis of covariance model fitted on the log-transformed titers; the model included intervention group as the fixed effect as well as age (continuous) and sex as covariates. dThe 95% CIs were constructed using the Clopper-Pearson method for SRR and the Farrington-Manning method for SRR difference.