بيانات النشر: Uppsala universitet, Centrum för klinisk forskning i Sörmland (CKFD)
Uppsala universitet, Institutionen för medicinsk biokemi och mikrobiologi
Colchester Res Grp, Truro, NS B2N 1L2, Canada.
PharmQuest, 806 Green Valley Rd Ste 305, Greensboro, NC 27408 USA.
Canadian Phase Onward Inc, Polyclin Family & Specialty Med Facil, Polyclin Family Hlth Grp, 2 Champagne Dr, Toronto, ON M3J 0K2, Canada.
Blekinge Inst Technol, Dept Hlth, Valhallavagen 1, SE-37179 Karlskrona, Sweden.;Lund Univ, Dept Clin Sci, BMC I12, SE-22184 Lund, Sweden.
GSK, Ave Fleming 20, B-1300 Wavre, Belgium.
GSK, Rue Inst 89, B-1330 Rixensart, Belgium.
نبذة مختصرة : Background Previous phase 3 studies showed that the AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine for older adults (RSVPreF3 OA) is well tolerated and efficacious in preventing RSV-associated lower respiratory tract disease in adults ≥ 60 years of age. This study evaluated lot-to-lot immunogenicity consistency, reactogenicity, and safety of three RSVPreF3 OA lots. Methods This phase 3, multicenter, double-blind study randomized (1:1:1) participants ≥ 60 years of age to receive one of three RSVPreF3 OA lots. Serum RSVPreF3-binding immunoglobulin G (IgG) concentration was assessed at baseline and 30 days post-vaccination. Lot-to-lot consistency was demonstrated if the two-sided 95 % confidence intervals (CIs) of the RSVPreF3-binding IgG geometric mean concentration (GMC) ratios between each lot pair at 30 days post-vaccination were within 0.67 and 1.50. Solicited adverse events (AEs) within four days, unsolicited AEs within 30 days, and serious AEs (SAEs) and potential immune-mediated diseases within six months post-vaccination were recorded. Results A total of 757 participants received RSVPreF3 OA, of whom 708 were included in the per-protocol set (234, 237, and 237 participants for each lot). Lot-to-lot consistency was demonstrated: GMC ratios were 1.06 (95 % CI: 0.94–1.21), 0.92 (0.81–1.04), and 0.87 (0.77–0.99) between the lot pairs (lot 1/2; 1/3; 2/3). For the three lots, the RSVPreF3-binding IgG concentration increased 11.84-, 11.29-, and 12.46-fold post-vaccination compared to baseline. The reporting rates of solicited and unsolicited AEs, SAEs, and potential immune-mediated diseases were balanced between lots. Twenty-one participants reported SAEs; one of these–a case of atrial fibrillation–was considered by the investigator as vaccine-related. SAEs with a fatal outcome were reported for four participants, none of which were considered by the investigator as vaccine-related. Conclusion This study demonstrated lot-to-lot immunogenicity ...
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