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
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
GlaxoSmithKline
108 participants
Jul 31, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Low dose Strep A Alum vaccine will be administered intramuscularly (IM)
Medium dose Strep A Alum vaccine will be administered IM
High dose Strep A Alum vaccine will be administered IM
Low dose Strep A AS37 vaccine will be administered IM
Medium dose Strep A AS37 vaccine will be administered IM
High dose Strep A AS37 vaccine will be administered IM
Strep A Alum Placebo will be administered IM
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07085702