A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Strep A Vaccine With Aluminum Hydroxide (Alum) or AS37 in Healthy Young Adults

The purpose of this study is to assess the safety of 3 doses of 2 new Strep A vaccine formulations, one with an Alum adjuvant, and the other with AS37 adjuvant. The Strep A vaccine will be tested for the first time in humans, in healthy young adults 18 to 25 years of age. The study will also assess if the vaccines have any immediate reactions and if they induce an immune response. A low, medium, and high dose of each formulation of the vaccine will be assessed in sequence.

NCT Number	NCT07085702
Lead Sponsor	GlaxoSmithKline Collaborators: HHS/BARDA, Wellcome Trust, DHSC/GAMRIF, Germany/BMBF, DG HERA (kfW)
Conditions	Streptococcal Infections
Enrollment	108 participants
Start Date	2025-07-29
Primary Completion	2027-06-29 (estimated)
Study Completion	2027-06-29 (estimated)
Updated on ClinicalTrials.gov	2026-08-11