Ireland
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Recruiting Phase 3

A Study on the Efficacy of a Vaccine Against Influenza in Adults ≥65 Years of Age

NCT07805707 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-09-02
Last updated
2026-09-18

Condition(s) studied

Influenza, Human

Investigational drug(s) / intervention(s)

mRNA Seasonal Flu vaccineLicensed Influenza Vaccine

mRNA Seasonal Flu vaccine: Single-dose intramuscular administration of the season-adapted investigational mRNA Seasonal Flu vaccine.

Licensed Influenza Vaccine: Single-dose intramuscular administration of an age-appropriate and season-adapted licensed influenza vaccine used as the active comparator.

Study summary

This study will compare an investigational mRNA flu vaccine with a licensed flu vaccine in adults 65 years of age and older. Participants will receive one injection and will be followed during the flu season. The study will measure prevention of laboratory-confirmed flu illness, side effects, and immune responses.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of a caregiver. 2. Written or witnessed (physically or digitally) informed consent obtained from the participant/Legally acceptable representative \[LAR(s)\] of the participant prior to performance of any study-specific procedure. 3. Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment 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. 4. A male or female participant at least 65 YOA at the time of the study intervention administration. Exclusion Criteria: 1. History of test-confirmed influenza infection within 180 days prior to study intervention administration. 2. Any confirmed or suspected immunosuppressive or immunodeficient condition. HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, their CD4 cell count is ≥ 200/mm³ and their viral load has been undetectable. 3. Hypersensitivity to latex. 4. History of myocarditis or pericarditis considered causally associated with mRNA vaccine. 5. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). 6. History of hypersensitivity or allergic reaction to any previous influenza vaccine. 7. History of hypersensitivity or allergic reaction to any previous mRNA vaccine. 8. History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine. 9. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study 10. Acute or unstable chronic conditions \[clinically significant pulmonary, cardiovascular, hepatic, metabolic/endocrine disorders, renal functional abnormality, or psychiatric conditions\], as determined by medical history and clinical examination. 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. Condition that in the judgment of the investigator would make intramuscular injection unsafe. 13. Administration of an influenza vaccine in the period starting 180 days before the study intervention administration or planned administration at any time during the study. 14. Planned administration/administration of any mRNA-based vaccine, live vaccine or adjuvanted protein-based vaccine in the period starting 30 days before the study intervention administration (Day -29 to Day 1) and ending 28 days after the study intervention administration (Day 1 to Day 28) or a non-replicating vaccine in the period starting 15 days before the study intervention administration (Day -14 to Day 1) and ending 14 days after the study intervention administration (Day 1 to Day 14). 15. Use of any investigational or non-registered product (drug, vaccine or invasive medical device in the country of enrollment) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or their planned use during the study period. 16. Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 90 days before the study intervention (Day -89 to Day 1) or planned administration during the study period. 17. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. * Up to 90 days prior to the study intervention administration: * For systemic corticosteroids: prednisone equivalent ≥20 mg/day for \>14 days. Inhaled, intra articular/intra-bursal, and topical steroids are allowed. * Long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication. 18. Administration of antitumoral medication during the period starting 90 days before the study intervention (Day -89 to Day 1) or planned administration during the study period. 19. Administration of any vaccine in a clinical trial investigating an influenza mRNA vaccine in the period starting 1 year before the study intervention administration. 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 (drug/invasive medical device). 21. For enrollment in Season 2: Previous participation (i.e., during previous season) in this clinical study. 22. Planned move during the study period that will prohibit participating in the study until study end. 23. Planned leave or holiday of 4 consecutive weeks or more during the influenza season covered by the study, that would prohibit the reporting of ILI cases and attendance to ILI visit. 24. Any study personnel or their immediate dependents, family, or household members.

Primary outcome measure(s)

  • Laboratory-confirmed protocol-defined influenza-like illness (ILI) assessed by incidence rate ratio — From Day 15 through the end of the influenza Season
    First occurrence of laboratory-confirmed protocol-defined ILI caused by influenza A subtypes and B lineage. Protocol-defined ILI is defined as the simultaneous occurrence of at least 1 respiratory symptom and at least 1 systemic symptom. Respiratory symptoms include nasal congestion, sore throat, new or increased sputum, new or increased cough, new or increased dyspnea, or wheezing. Systemic symptoms include temperature \>37.2°C/99°F or feverishness, fatigue, myalgia, or headache. The endpoint will be assessed using an incidence rate approach. Relative vaccine efficacy will be calculated as 100 × (1 - incidence rate ratio).
  • Number of Participants with Solicited Administration Site Adverse Events (AEs) — From Day 1 to Day 7
    The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy. Lymphadenopathy is defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm.
  • Number of Participants with Solicited Systemic AEs — From Day 1 to Day 7
    The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills. Fever is defined as temperature greater than or equal to (\>=) 38 °C/100.4 °F regardless the location of measurement.
  • Number of Participants with Unsolicited AEs — From Day 1 to Day 28
    An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
  • Number of Participants with Serious Adverse Events (SAEs) — From Day 1 up to the end of the influenza season (with at least 180 days of follow-up)
    SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.
  • Number of Participants with Adverse Events of Special Interest (AESIs) — From Day 1 up to the end of the influenza season (with at least 180 days of follow-up)
    An adverse event of special interest is an adverse event of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate. AESIs include protocol-defined events such as potential immune-mediated disorders, myocarditis, pericarditis, severe hypersensitivity reactions, and other AESIs defined in the protocol.
  • Number of Participants with any Laboratory abnormalities — At Day 1 (pre-dose) and at Day 29 (post -dose)

Trial sites (163)

FacilityCityRegionStatus
GSK Investigational Site Anniston Alabama Recruiting
GSK Investigational Site Guntersville Alabama Recruiting
GSK Investigational Site Glendale Arizona Recruiting
GSK Investigational Site Mesa Arizona Recruiting
GSK Investigational Site Mesa Arizona Recruiting
GSK Investigational Site Phoenix Arizona Recruiting
GSK Investigational Site Phoenix Arizona Recruiting
GSK Investigational Site Scottsdale Arizona Recruiting
GSK Investigational Site Scottsdale Arizona Recruiting
GSK Investigational Site Sun City Arizona Recruiting
GSK Investigational Site Tempe Arizona Recruiting
GSK Investigational Site Tempe Arizona Recruiting
GSK Investigational Site Tucson Arizona Recruiting
GSK Investigational Site Tucson Arizona Recruiting
GSK Investigational Site Little Rock Arkansas Recruiting
GSK Investigational Site Little Rock Arkansas Recruiting
GSK Investigational Site Dublin California Recruiting
GSK Investigational Site Escondido California Recruiting
GSK Investigational Site Fair Oaks California Recruiting
GSK Investigational Site La Palma California Recruiting
GSK Investigational Site Redding California Recruiting
GSK Investigational Site Riverside California Recruiting
GSK Investigational Site Rolling Hills Estates California Recruiting
GSK Investigational Site San Bernardino California Recruiting
GSK Investigational Site San Diego California Recruiting
GSK Investigational Site Walnut Creek California Recruiting
GSK Investigational Site Aurora Colorado Recruiting
GSK Investigational Site Colorado Springs Colorado Recruiting
GSK Investigational Site Stamford Connecticut Recruiting
GSK Investigational Site Waterbury Connecticut Recruiting
GSK Investigational Site Altamonte Springs Florida Recruiting
GSK Investigational Site Fort Lauderdale Florida Recruiting
GSK Investigational Site Hialeah Florida Recruiting
GSK Investigational Site Hialeah Florida Recruiting
GSK Investigational Site Homestead Florida Recruiting
GSK Investigational Site Lake Mary Florida Recruiting
GSK Investigational Site Lake Worth Florida Recruiting
GSK Investigational Site Maitland Florida Recruiting
GSK Investigational Site Melbourne Florida Recruiting
GSK Investigational Site Miami Florida Recruiting

+ 123 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07805707 on ClinicalTrials.gov ↗ ← All trials in the USA