A Study to Assess the Immune Response and Safety of a Vaccine Against Influenza in Adults 18 Years of Age and Older
NCT ID: NCT07121192
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
776 participants
INTERVENTIONAL
2025-08-25
2026-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Flu mRNA_1_YA
Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1.
Flu mRNA (Formulation A)
One dose of Flu mRNA (Formulation A) received intramuscularly.
Flu mRNA_2_YA
Eligible YA participants receive a single dose of Flu mRNA Formulation B (GSK6479715A) as study intervention at Day 1.
Flu mRNA (Formulation B)
One dose of Flu mRNA (Formulation B) received intramuscularly.
Comparator_1_YA
Eligible YA participants receive a single dose of comparator 1 at Day 1.
Comparator 1
One dose of Comparator 1 received intramuscularly.
Comparator_2_YA
Eligible YA participants receive a single dose of comparator 2 at Day 1.
Comparator 2
One dose of Comparator 2 received intramuscularly.
Flu mRNA_1_OA
Eligible Older Adults (OA) participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1.
Flu mRNA (Formulation A)
One dose of Flu mRNA (Formulation A) received intramuscularly.
Flu mRNA_2_OA
Eligible OA participants receive a single dose of Flu mRNA Formulation B (GSK6479715A) as study intervention at Day 1.
Flu mRNA (Formulation B)
One dose of Flu mRNA (Formulation B) received intramuscularly.
Comparator_1_OA
Eligible OA participants receive a single dose of comparator 1 at Day 1.
Comparator 1
One dose of Comparator 1 received intramuscularly.
Comparator_2_OA
Eligible OA participants receive a single dose of comparator 2 at Day 1.
Comparator 2
One dose of Comparator 2 received intramuscularly.
Comparator_3_OA
Eligible OA participants receive a single dose of comparator 3 at Day 1.
Comparator 3
One dose of Comparator 3 received intramuscularly.
Interventions
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Flu mRNA (Formulation A)
One dose of Flu mRNA (Formulation A) received intramuscularly.
Flu mRNA (Formulation B)
One dose of Flu mRNA (Formulation B) received intramuscularly.
Comparator 1
One dose of Comparator 1 received intramuscularly.
Comparator 2
One dose of Comparator 2 received intramuscularly.
Comparator 3
One dose of Comparator 3 received intramuscularly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Written (physically, or digitally) informed consent obtained from the participant prior to performance of any study-specific procedure.
3. A male or female at least 18 YOA at the time of the screening.
4. Healthy participants or medically stable patients as established by medical history, and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, neurologic, and hematologic diseases) are allowed to participate in this study, if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment.
5. Female participants of non-childbearing potential may be enrolled in the clinical study.
6. Female participants of childbearing potential may be enrolled in the clinical study, if the participant:
* Has practiced adequate contraception for at least 4 weeks prior to the study intervention administration, and
* Has a negative urine pregnancy test within 24 hours prior to the study intervention administration, and
* Has agreed to continue adequate contraception for at least 8 weeks after study intervention administration.
7. Body mass index (BMI) between18 kg/m\^² and 33kg/m\^².
Exclusion Criteria
2. Immunosuppressive or immunodeficient conditions by history/exam; stable HIV-positive individuals on therapy can participate.
3. History of Guillain-Barré Syndrome within 6 weeks of receiving any vaccine.
4. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year).
5. Hypersensitivity to latex.
6. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
7. History of hypersensitivity or severe allergic reaction to any previous influenza vaccine.
8. History of hypersensitivity or severe allergic reaction to any previous mRNA vaccine.
9. History of or current suspicion of myocarditis or pericarditis, or medical issues increasing such risks.
10. Condition that in the judgment of the investigator would make intramuscular injection unsafe.
11. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
12. History of confirmed influenza infection by local health authority-approved testing methods within 180 days prior to study intervention administration.
13. Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 28 days before the dose of study intervention(s) (Day -28 to Day 1), or their planned use during the study period.
14. Administration of an influenza vaccine within 180 days before the study intervention administration or planned administration prior to Visit 4 (Day 29) during the study.
15. Administration of any non-live attenuated non-study vaccine in the period starting 14 days before the study intervention administration, or planned administration within 14 days after study intervention administration.
16. Administration of any live attenuated and/or mRNA non-study non-influenza vaccine in the period starting 28 days before the study intervention administration, or planned administration within 28 days after study intervention administration.
17. Chronic administration of immune-modifying drugs.
18. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention, or planned administration during the study period.
19. Administration of anti-tumoral medication during the period starting 90 days before the study intervention or planned administration during the study period.
20. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.
21. Any study personnel or their immediate dependents, family, or household members.
22. Has a history of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
23. Participant is pregnant.
24. Participant is breastfeeding or will (re)start breastfeeding during the study.
18 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Anniston, Alabama, United States
GSK Investigational Site
Fair Oaks, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Jupiter, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Valparaiso, Indiana, United States
GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
Springfield, Massachusetts, United States
GSK Investigational Site
Carson City, Nevada, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
Greensboro, North Carolina, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
North Charleston, South Carolina, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
DeSoto, Texas, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
Newport News, Virginia, United States
GSK Investigational Site
Seattle, Washington, United States
Countries
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Other Identifiers
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300356
Identifier Type: -
Identifier Source: org_study_id
2025-522278-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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