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RECRUITING
NCT07085702
PHASE1

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2025-07-31

Completion Date

2026-11-30

Last Updated

2025-08-11

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Low dose Strep A Alum

Low dose Strep A Alum vaccine will be administered intramuscularly (IM)

BIOLOGICAL

Medium dose Strep A Alum

Medium dose Strep A Alum vaccine will be administered IM

BIOLOGICAL

High dose Strep A Alum

High dose Strep A Alum vaccine will be administered IM

BIOLOGICAL

Low dose Strep A AS37

Low dose Strep A AS37 vaccine will be administered IM

BIOLOGICAL

Medium dose Strep A AS37

Medium dose Strep A AS37 vaccine will be administered IM

BIOLOGICAL

High dose Strep A AS37

High dose Strep A AS37 vaccine will be administered IM

DRUG

Strep A Alum Placebo

Strep A Alum Placebo will be administered IM

Locations (2)

GSK Investigational Site

Botany, New South Wales, Australia

GSK Investigational Site

Camberwell, Victoria, Australia