A Study to Evaluate the Immune Response and Safety of an Influenza Vaccine in Adults 18 Years of Age and Above
NCT ID: NCT07204964
Last Updated: 2025-12-04
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
960 participants
INTERVENTIONAL
2025-10-07
2026-09-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Immune Response and Safety of a Vaccine Against Influenza in Adults 18 Years of Age and Older
NCT07121192
A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults
NCT06431607
A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
NCT05823974
A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
NCT05446740
A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
NCT05333289
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Flu mRNA_1_YA
Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA Formulation B1 (GSK6498032A) as study intervention at Day 1.
Flu mRNA (Formulation B1)
One dose of Flu mRNA (Formulation B1) received intramuscularly.
Flu mRNA_3_YA
Eligible YA participants receive a single dose of Flu mRNA Formulation B3 (GSK6498032A) as study intervention at Day 1.
Flu mRNA (Formulation B3)
One dose of Flu mRNA (Formulation B3) received intramuscularly.
Flu mRNA_4_YA
Eligible 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.
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 B1 (GSK6498032A) as study intervention at Day 1.
Flu mRNA (Formulation B1)
One dose of Flu mRNA (Formulation B1) received intramuscularly.
Flu mRNA_3_OA
Eligible YA participants receive a single dose of Flu mRNA Formulation B3 (GSK6498032A) as study intervention at Day 1.
Flu mRNA (Formulation B3)
One dose of Flu mRNA (Formulation B3) received intramuscularly.
Flu mRNA_4_OA
Eligible 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.
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 3 at Day 1.
Comparator 3
One dose of Comparator 3 received intramuscularly.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Flu mRNA (Formulation B1)
One dose of Flu mRNA (Formulation B1) received intramuscularly.
Flu mRNA (Formulation B3)
One dose of Flu mRNA (Formulation B3) received intramuscularly.
Flu mRNA(Formulation A)
One dose of Flu mRNA (Formulation A) 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
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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. Current or chronic conditions related with EXC criteria 1.
3. Immunosuppressive or immunodeficient conditions by history/exam; stable HIV-positive individuals on therapy can participate.
4. History of Guillain-Barré Syndrome within 6 weeks of receiving any vaccine.
5. 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).
6. Hypersensitivity to latex.
7. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
8. History of hypersensitivity or allergic reaction to any previous influenza vaccine.
9. History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
10. History of or current suspicion of myocarditis or pericarditis or medical condition increasing such risks.
11. Condition that in the judgment of the investigator would make intramuscular injection unsafe.
12. 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.
13. History of confirmed influenza infection by local health authority-approved testing methods within 180 days prior to study intervention administration.
14. 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.
15. 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.
16. 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.
17. 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
18. Chronic administration of immune-modifying drugs.
19. 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.
20. Administration of antitumoral medication during the period starting 90 days before the study intervention or planned administration during the study period.
21. 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.
22. Any study personnel or their immediate dependents, family, or household members.
23. 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.
24. Participant is pregnant.
25. Participant is breastfeeding or will (re)start breastfeeding during the study.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Guntersville, Alabama, United States
GSK Investigational Site
Canoga Park, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Pembroke Pines, Florida, United States
GSK Investigational Site
Stockbridge, Georgia, United States
GSK Investigational Site
Carson City, Nevada, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Greensboro, North Carolina, United States
GSK Investigational Site
North Charleston, South Carolina, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Garland, Texas, United States
GSK Investigational Site
Newport News, Virginia, United States
GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Edegem, , Belgium
GSK Investigational Site
Ghent, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-522599-97-00
Identifier Type: CTIS
Identifier Source: secondary_id
300336
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.