Trials / Completed
CompletedNCT06431607
A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults
A Phase 2a Randomized, Observer-blind, Dose-finding Study to Evaluate the Immunogenicity and Safety of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates in Adults 18 Years of Age and Older
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 845 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent vaccine (GSK4382276A) candidate against influenza, administered in healthy younger adults (YA) and older adults (OA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | F2G22B/DL001Z | Study intervention was administered intramuscularly at Day 1. |
| BIOLOGICAL | F2H23D/DL001Z-NH | Study intervention was administered intramuscularly at Day 1. |
| BIOLOGICAL | F2H23B/DL001Z-NH | Study intervention was administered intramuscularly at Day 1. |
| BIOLOGICAL | F2H23H/DL001Z | Study intervention was administered intramuscularly at Day 1. |
| COMBINATION_PRODUCT | FDQ23A-NH (Flu D-QIV) | Control Vaccine was administered intramuscularly at Day 1. |
| BIOLOGICAL | GSK5800544A | Study intervention was administered intramuscularly at Day 1. |
| COMBINATION_PRODUCT | Flu D-TIV | Control Vaccine was administered intramuscularly at Day 1. |
| BIOLOGICAL | F2H23A/DL001Z-NH | Study intervention was administered intramuscularly at Day 1. |
| BIOLOGICAL | F2H23G/DL001Z | Study intervention was administered intramuscularly at Day 1. |
| COMBINATION_PRODUCT | Fluzone HD Quadrivalent | Control vaccine was administered intramuscularly at Day 1. |
| COMBINATION_PRODUCT | Fluzone HD | Control vaccine was administered intramuscularly at Day 1. |
Timeline
- Start date
- 2024-05-23
- Primary completion
- 2024-12-27
- Completion
- 2025-06-04
- First posted
- 2024-05-28
- Last updated
- 2026-03-10
- Results posted
- 2026-03-10
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06431607. Inclusion in this directory is not an endorsement.