Actively Recruiting
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
Led by GlaxoSmithKline · Updated on 2025-08-11
108
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
Sponsors
G
GlaxoSmithKline
Lead Sponsor
H
HHS/BARDA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants able and willing to comply with study requirements including completing electronic diaries and follow-up visits
- Provided written or witnessed/thumb-printed informed consent before any study procedures
- Healthy as confirmed by medical history, clinical exam, and lab tests
- Meet all screening requirements
- Male or female aged 18 to 25 years at consent
- Females of nonchildbearing potential (e.g., premenarche, postmenopause, or certain surgeries) eligible
- Females of childbearing potential must use effective contraception for 1 month before and during vaccination, have a negative pregnancy test on vaccination day, and agree to continue contraception for 1 month after last dose
- Males sexually active with females of childbearing potential must ensure partner uses effective contraception from 1 month before first dose until 1 month after last dose
- Males must avoid sperm donation from 1 month before first dose until 1 month after last dose
- Negative for HIV, hepatitis B, and hepatitis C at screening
You will not qualify if you...
- History of rheumatic fever or rheumatic heart disease
- Recent pharyngitis within 4 weeks, or positive Strep A rapid test if symptomatic
- Progressive, unstable, or uncontrolled clinical conditions
- Known or suspected hypersensitivity to vaccine components
- Immunosuppressive or immunodeficient conditions
- Allergies to study medicinal products or equipment
- Conditions contraindicating intramuscular vaccination or blood draws
- Behavioral or psychiatric conditions interfering with participation
- Acute illness or fever (temperature 6438.0�b0C) at enrollment
- Significant hematological or biochemical lab abnormalities
- Echocardiographic findings of carditis
- History of uncontrolled neurological disorders or seizures
- Personal or family history of autoimmune disease or acute rheumatic fever
- Significant pulmonary, cardiovascular, hepatic, or renal abnormalities
- Use of long-acting immune-modifying drugs before or during study
- Prior receipt of experimental Strep A vaccine
- Use of investigational or nonregistered products within 30 days before first dose or planned use during study
- Receipt of non-study vaccines within 21 or 28 days before first dose
- Immunoglobulins, blood products, or bone marrow transplant within 3 months before first dose or planned during study
- Chronic immunosuppressant use exceeding 14 days within 3 months before first dose
- Participation in another clinical study involving investigational or invasive interventions
- Pregnant or lactating females
- Planning pregnancy or to stop contraception
- History of chronic alcohol or drug abuse
- Study staff or immediate family members involved in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
GSK Investigational Site
Botany, New South Wales, Australia, 2019
Actively Recruiting
2
GSK Investigational Site
Camberwell, Victoria, Australia, 3124
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here