Table 2.
Non-inferiority analysis as measured by the GMT ratio between titres of serum nAbs against the SARS-CoV-2 ancestral strain at day 15 in this study (TAK-019-3001; per protocol set) and those at day 36 in the TAK-019-1501 study (NCT04712110).
| TAK-019-3001 (n = 148) |
TAK-019-1501, (n = 150) |
|
|---|---|---|
| GMT (95 % CI) pre-dose day 1a | 10.0 (10.0–10.1) | |
| GMT (95 % CI) pre-dose day 22b | 50.2 (41.2–61.0) | |
| GMT (95 % CI) pre-booster dosec | 137.1 (112.0–167.7) | |
| GMT (95 % CI)d | 1143.9 (1000.5–1307.9) | 884.4 (749.0–1044.4) |
| GMT by LS means of ANOVA | 981.7 | 829.7 |
| GMTRTAK-019-3001/TAK-019-1501 (95 % CI) | 1.18 (0.95–1.47)e |
ANOVA; analysis of variance; CI, confidence interval; GMT; geometric mean titre; GMTR, geometric mean titre ratio; LS; least squares; nAb, neutralizing antibody; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
Before the first dose of the primary series of NVX-CoV2373.
Before the second dose of the primary series of NVX-CoV2373.
Baseline levels of participants in this study.
On day 15 in this study and day 36 in the TAK-019-1501 study.
Predefined criterion for non-inferiority: lower limit of 95 % CI of GMTR ≥ 0.67.