A Study on the Efficacy of a Vaccine Against Influenza in Adults ≥65 Years of Age
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More GlaxoSmithKline trials in the USA
Other trials for the same condition
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