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3000 Participants NeededMy employer runs this trial

mRNA Vaccine for Flu

Recruiting at 11 trial locations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 3
Sponsor: GlaxoSmithKline
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial will study an investigational seasonal influenza vaccine in adults 18 to 64 years of age. The vaccine is based on messenger ribonucleic acid, also called mRNA. The main goals of the study are to learn how well the vaccine helps the body make an immune response against influenza and what medical problems participants may have after vaccination. Researchers will also compare immune responses in adults 18 to 64 years of age from this study, with immune responses in adults 65 years of age and older from another study. Participants will receive 1 injection into the upper arm muscle and will be followed for about 6 months.

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 64 who can follow study instructions. Women must have a negative pregnancy test and use contraception before and after the vaccine. Participants need to be able to attend visits and communicate electronically.

Inclusion Criteria

I am between 18 and 64 years old.
Participants who can and will comply with the requirements of the protocol independently or with caregiver assistance, including completion of eDiary, follow-up visits, study contacts, and use of phone or electronic communications
Participants of childbearing potential who have practiced adequate contraception for at least 30 days prior to study intervention administration
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Exclusion Criteria

I have an immune system problem, unless my HIV is stable as defined by the study.
I have had heart inflammation after receiving an mRNA vaccine.
I had Guillain-Barré syndrome within 6 weeks after a vaccine.
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • mRNA Seasonal Flu vaccine

Trial Overview

The study tests an mRNA-based seasonal flu vaccine, given as one shot in the upper arm. Researchers will monitor immune response and safety over about six months, comparing results with other age groups from separate studies.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: mRNA Seasonal Flu Vaccine - Cohort 2Experimental Treatment1 Intervention
Group II: mRNA Seasonal Flu Vaccine - Cohort 1Experimental Treatment1 Intervention
Group III: Comparator 1_Cohort 1Active Control1 Intervention
Group IV: Comparator 2_Cohort 2Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

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