GSK discloses FDA hold on infant pneumococcal vaccine study; posts two Phase 3/4 results

GSK's registry activity for the week of October 9, 2026 included a safety disclosure, two completed-trial results postings, and several newly registered or ongoing studies.

• A completed Phase 2 trial of the investigational pneumococcal vaccine AFX3772 in 388 healthy infants posted results, and the posting discloses that on 31 October 2024 the study was placed on partial clinical hold by the U.S. Food and Drug Administration, a hold not related to safety concerns in participants who had already received the study vaccines, after which enrollment was paused and no further doses of the investigational vaccine were administered.¹ Enrolled participants who were already in the study transitioned to the standard of care pneumococcal vaccine to complete their scheduled visits through post-dose 3 and subsequently completed study follow-up.¹
• A completed Phase 3 trial comparing long-term safety of salbutamol delivered via metered dose inhalers containing the propellant HFA-152a against reference propellant HFA-134a in adults with asthma enrolled 471 participants who received either 200 microgram salbutamol HFA-152a or 200 microgram HFA-134a once daily plus as-needed dosing up to 800 micrograms², with results first posted October 6, 2026.
• A Phase 4 trial comparing the triple combination fluticasone furoate/umeclidinium bromide/vilanterol delivered via the Ellipta inhaler with non-Ellipta usual care ICS/LABA in uncontrolled asthma is listed as active, not recruiting, after enrolling 1358 participants randomized to receive a once-daily fixed-dose combination of 100 microgram fluticasone furoate, 62.5 microgram umeclidinium, and 25 microgram vilanterol via the Ellipta dry powder inhaler for up to 24 weeks³, with results first posted October 6, 2026.
• GSK registered a new Phase 1 study assessing how moderate or severe renal impairment affects the pharmacokinetics, safety, and tolerability of velzatinib compared with normal renal function; the trial is not yet recruiting and plans to enroll 30 participants⁴.
• A Phase 3 trial of an mRNA-based seasonal influenza vaccine in adults 18 to 64 years of age, first posted October 1, 2026 and last updated October 9, 2026, remains recruiting; the study plans to enroll 3000 participants⁵ and compares immune responses against influenza antigens following a single intramuscular dose.
• GSK registered a new Phase 1 study examining how the proton pump inhibitor omeprazole and the P-gp/BCRP inhibitor cyclosporine affect the pharmacokinetics, safety, and tolerability of velzatinib in healthy volunteers; the trial is not yet recruiting and plans to enroll 36 participants⁶.
• GSK registered the Phase 1b/Phase 3 "SAPPHIRE" study comparing subcutaneous and intravenous dostarlimab, each paired with carboplatin and paclitaxel, in patients with primary advanced or recurrent endometrial cancer; it is not yet recruiting and plans to enroll 380 participants⁷ across dose-finding and randomized phases.
• GSK registered a Japan-based open-label extension study, "J-LINX," evaluating long-term safety of linerixibat in Japanese adults with cholestatic pruritus associated with primary biliary cholangitis who previously completed the LLSAT study; it is not yet recruiting and plans to enroll 40 participants⁸.
• GSK registered a new Phase 1 study assessing how hepatic impairment affects the pharmacokinetics and safety of velzatinib compared with participants who have normal liver function; it is not yet recruiting and plans to enroll 40 participants with mild, moderate, and severe hepatic impairment and participants with normal hepatic function⁹.