clinical trial · NCT07085702
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
Streptococcal InfectionsLow dose Strep A AlumMedium dose Strep A AlumHigh dose Strep A AlumLow dose Strep A AS37Medium dose Strep A AS37High dose Strep A AS37Strep A Alum Placebo
brief summary
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.
started
Jul 29, 2025
primary completion
Jun 29, 2027
completion
Jun 29, 2027
last updated
Aug 11, 2026
official title
A Phase 1 Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Vaccine Against Group A Streptococcus Pyogenes (Strep A) With Alum or AS37 in Healthy Adults 18 to 25 Years of Age in Australia
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol