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Virus Therapy
Combination Vaccine for Flu and COVID-19
Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
History of uncontrolled neurological disorders, seizures, myocarditis, or pericarditis
Use of investigational or non-registered products, mRNA-based vaccines, or specific therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 to day 29, from day 1 to day 92 and from day 1 to day 183 (study end)
Summary
This trial will test a combination vaccine that targets both the flu virus and the COVID-19 virus in healthy adults. The vaccine has already been tested separately for each virus, and this study will evaluate its
Who is the study for?
This trial is for healthy adults who are interested in receiving a combination vaccine that targets both the flu and COVID-19. Specific eligibility criteria were not provided, but typically participants should not have conditions that could interfere with the study or pose additional health risks.
What is being tested?
The trial is testing a new combo vaccine for flu and COVID-19. It's looking at how people react to it, its safety, and if it triggers an immune response. The study will compare different doses of this combined mRNA vaccine against separate flu and COVID-19 vaccines.
What are the potential side effects?
While specific side effects aren't listed here, common reactions to vaccines include soreness at injection site, fever, fatigue, headache, muscle pain. Since this combines flu & COVID-19 vaccines, there may be similar side effects.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled neurological disorders, seizures, myocarditis, or pericarditis.
Select...
I am not currently using any experimental drugs or vaccines.
Select...
I have been in close contact with someone who had the flu or COVID-19 recently.
Select...
I have a bleeding disorder or have had significant bleeding after injections.
Select...
I have a condition that weakens my immune system.
Select...
I am not on long-term immune-modifying drugs or blood products.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 to day 29, from day 1 to day 92 and from day 1 to day 183 (study end)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 29, from day 1 to day 92 and from day 1 to day 183 (study end)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) in Phase 2
Percentage of participants with adverse events of special interest (AESIs) in Phase 1 and in Phase 2 (selected study intervention from Phase1)
Percentage of participants with increase in grading for at least one laboratory value from administration of study intervention in Phase 1
+5 moreSecondary study objectives
GMI in antigen 1 antibody in Phase 2 selected investigational mRNA Flu/COVID-19 vaccine from Phase 1, mRNA Flu Seasonal vaccine and the licensed Flu vaccine co-administered with a licensed mRNA COVID-19 vaccine
GMI in antigen 2 antibody in Phase 1 for the investigational mRNA Flu/COVID-19 vaccines, mRNA Flu Seasonal vaccine and the licensed Flu Seasonal vaccine co-administered with a licensed mRNA COVID-19 vaccine
GMI in antigen 2 antibody in Phase 2 selected investigational mRNA Flu/COVID-19 vaccine from Phase 1, mRNA Flu Seasonal vaccine and the licensed Flu vaccine co-administered with a licensed mRNA COVID-19 vaccine
+8 moreTrial Design
14Treatment groups
Experimental Treatment
Active Control
Group I: mRNA Flu/COVID-19 _YA GroupExperimental Treatment2 Interventions
Younger adult (YA,18-64 years of age) participants receive one dose of a selected Investigational Flu Seasonal/SARS-CoV-2 mRNA dose level from study Phase 1 and 1 dose of placebo on Day 1.
Group II: mRNA Flu/COVID-19 _OA GroupExperimental Treatment2 Interventions
Older adult (OA; 65 years of age and older) participants receive one dose of a selected Investigational Flu Seasonal/SARS-CoV-2 mRNA dose level from study Phase 1 and 1 dose of placebo on Day 1.
Group III: mRNA Flu/COVID-19 Dose 2 GroupExperimental Treatment2 Interventions
Participants receive one dose of investigational Flu mRNA vaccine composition in combination with a Dose 2 of a COVID-19 component and 1 dose of placebo on Day 1.
Group IV: mRNA Flu/COVID-19 Dose 1 GroupExperimental Treatment2 Interventions
Participants receive one dose of investigational Flu mRNA vaccine composition in combination with a Dose 1 of a COVID-19 component and 1 dose of placebo on Day 1.
Group V: Flu+COVID-19 GroupActive Control2 Interventions
Participants receive one dose of a licensed Flu Seasonal vaccine and a licensed mRNA COVID-19 vaccine on Day 1.
Group VI: mRNA Flu GroupActive Control2 Interventions
Participants receive one dose of an investigational mRNA Flu Seasonal vaccine and 1 dose of placebo on Day 1.
Group VII: mRNA COVID-19 Dose 2 GroupActive Control2 Interventions
Participants receive one dose of Dose 2 investigational mRNA COVID-19 vaccine and 1 dose of placebo on Day 1.
Group VIII: mRNA Flu _OA GroupActive Control2 Interventions
OA participants receive one dose of an investigational mRNA Flu Seasonal vaccine and 1 dose of placebo on Day 1.
Group IX: mRNA COVID-19 Dose 1 GroupActive Control2 Interventions
Participants receive one dose of Dose 1 investigational mRNA COVID-19 vaccine and 1 dose of placebo on Day 1.
Group X: Flu+COVID-19 _YA GroupActive Control2 Interventions
YA participants receive one dose of a licensed Flu Seasonal vaccine and a licensed mRNA COVID-19 vaccine on Day 1.
Group XI: mRNA COVID-19 _OA GroupActive Control2 Interventions
OA participants receive one dose of a selected SARS-CoV-2 mRNA dose level from study Phase 1 together and 1 dose of placebo on Day 1.
Group XII: mRNA Flu _YA GroupActive Control2 Interventions
YA participants receive one dose of an investigational mRNA Flu Seasonal vaccine and 1 dose of placebo on Day 1.
Group XIII: mRNA COVID-19 _YA GroupActive Control2 Interventions
YA participants receive one dose of a selected SARS-CoV-2 mRNA dose level from study Phase 1 and 1 dose of placebo on Day 1.
Group XIV: Flu+COVID-19 _OA GroupActive Control2 Interventions
OA participants receive one dose of a licensed Flu Seasonal vaccine and a licensed mRNA COVID-19 vaccine on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,383,410 Total Patients Enrolled