regards to having at least one prespecified medical condition, which included 53% with ≥1 chronic pulmonary condition, 8% with ≥1 cardiovascular condition, 42% with diabetes and 31% ≥1 other disease (liver, renal, neurologic, haematologic or other metabolic disease). Vaccine efficacy in individuals 18 through 59 years of age is inferred by immunobridging to study 2 where vaccine efficacy was demonstrated in individuals 60 years of age and older.
The non-inferiority criteria were met for high risk individuals 18 through 59 years of age compared to a randomly selected immunogenicity subset (external control group) of individuals ≥60 years of age from study 2 for the ratio of RSV neutralising geometric mean titres (GMTs) by the lower bounds of the 2-sided 95% CIs >0.667 (1.5-fold non-inferiority margin), and for the difference in seroresponse rates by the lower bounds of the 2-sided 95% CIs > -10% for both RSV A and RSV B.
Table 7 Comparison of model adjusted RSV neutralising titre GMTs at 1 month after vaccination with Abrysvo, 18 through 59 years at high risk (Study 3) versus 60 years and older (Study 2) CI – confidence interval; GMR – geometric mean ratio; GMT – geometric mean titre Table 8 Comparison of RSV neutralising titre seroresponse rates 1 month after vaccination with Abrysvo, 18 through 59 years at high risk (Study 3) versus 60 years and older (Study 2) CI – confidence interval 5.2 Pharmacokinetic properties Not applicable.
5.3 Preclinical safety data Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity to reproduction and development. 6.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Powder Trometamol Trometamol hydrochloride Sucrose Mannitol (E421) 10 Study 3 18-59 years of age at high risk Study 2 ≥60 years ANCOVA comparison RSV subgroups n Adjusted GMT (95% CI) n Adjusted GMT (95% CI) Adjusted GMR (95% CI) A 435 41 097 (37 986, 44 463) 408 26 225 (24 143, 28 486) 1.57 (1.396, 1.759) B 437 37 416 (34 278, 40 842) 408 24 680 (22 504, 27 065) 1.52 (1.333, 1.725) Study 3 18-59 years of age at high risk Study 2 ≥60 years Comparison RSV subgroups n/N (%) 95% CI n/N (%) 95% CI Difference (95% CI) A 405/435 (93) 90.3, 95.3 359/408 (88) 84.4, 91.0 5.1 (1.2, 9.2) B 408/437 (93) 90.6, 95.5 347/408 (85) 81.2, 88.4 8.3 (4.2, 12.6)