A Study to Evaluate the Immune Response and Safety of a Vaccine Against Influenza in Adults 18-64 Years of Age
Condition(s) studied
Investigational drug(s) / intervention(s)
mRNA Seasonal Flu vaccine: One dose of the mRNA Flu vaccine received intramuscularly.
Comparator 1: One dose of the comparator vaccine received intramuscularly.
Comparator 2: One dose of the comparator vaccine received intramuscularly.
Study summary
This clinical trial will study an investigational seasonal influenza vaccine in adults 18 to 64 years of age. The vaccine is based on messenger ribonucleic acid, also called mRNA. The main goals of the study are to learn how well the vaccine helps the body make an immune response against influenza and what medical problems participants may have after vaccination. Researchers will also compare immune responses in adults 18 to 64 years of age from this study, with immune responses in adults 65 years of age and older from another study. Participants will receive 1 injection into the upper arm muscle and will be followed for about 6 months.
Eligibility
Primary outcome measure(s)
- Geometric Mean Titer (GMT) of Antigen 1 Titer — At Day 29
- GMT of Antigen 2 Titer — At Day 29
- Percentage of participants with Antigen 1 seroconversion rate (SCR) — From Day 1 to Day 29
- Number of participants with solicited administration site adverse events — Day 1 to Day 7
- Number of participants with systemic adverse events — Day 1 to Day 7
- Number of participants with unsolicited adverse events — Day 1 to Day 28
- Number of participants with serious adverse events (SAEs) — Day 1 to Day 181
- Number of participants with adverse events of special interest (AESIs) — Day 1 to Day 181
- Number of Participants with any Laboratory abnormalities — At Day 1 (pre-dose) and at Day 29 (post - dose)
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Glendale | Arizona | Recruiting |
| GSK Investigational Site | Tucson | Arizona | Recruiting |
| GSK Investigational Site | San Diego | California | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Miami Lakes | Florida | Recruiting |
| GSK Investigational Site | Meridian | Idaho | Recruiting |
| GSK Investigational Site | Valparaiso | Indiana | Recruiting |
| GSK Investigational Site | Lenexa | Kansas | Recruiting |
| GSK Investigational Site | Hartsdale | New York | Recruiting |
| GSK Investigational Site | Spartanburg | South Carolina | Recruiting |
| GSK Investigational Site | DeSoto | Texas | Recruiting |
| GSK Investigational Site | Fort Worth | Texas | Recruiting |
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 NCT07851246 on ClinicalTrials.gov ↗ ← All trials in the USA