Trials / Completed
CompletedNCT05446740
A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
A Phase 1 Randomized, Dose Escalation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an mRNA-based Monovalent Influenza Vaccine Candidate in Healthy Younger and Older Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 324 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in healthy younger adults (YA) and older adults (OA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK4382276A Dose level 1 | Single dose of intervention administered at Day 1 |
| BIOLOGICAL | GSK4382276A Dose level 2 | Single dose of intervention administered at Day 1 |
| BIOLOGICAL | GSK4382276A Dose level 3 | Single dose of intervention administered at Day 1 |
| BIOLOGICAL | GSK4382276A Dose level 4 | Single dose of intervention administered at Day 1 |
| BIOLOGICAL | GSK4382276A Dose level 5 | Single dose of intervention administered at Day 1 |
| BIOLOGICAL | GSK4382276A Dose level 6 | Single dose of intervention administered at Day 1 |
| BIOLOGICAL | GSK4382276A Dose level 7 | Single dose of intervention administered at Day 1 |
| BIOLOGICAL | GSK4382276A Dose level 8 | Single dose of intervention administered at Day 1 |
| BIOLOGICAL | GSK4382276A Dose level 9 | Single dose of intervention administered at Day 1 |
| BIOLOGICAL | GSK4382276A Dose level 10 | Single dose of intervention administered at Day 1 |
| COMBINATION_PRODUCT | FDQ21A-NH | Single dose of intervention administered at Day 1 |
| COMBINATION_PRODUCT | FDQ22A-NH | Single dose of intervention administered at Day 1 |
Timeline
- Start date
- 2022-08-09
- Primary completion
- 2024-03-26
- Completion
- 2024-03-26
- First posted
- 2022-07-07
- Last updated
- 2026-03-10
- Results posted
- 2026-03-10
Locations
7 sites across 3 countries: Belgium, Canada, Spain
Source: ClinicalTrials.gov record NCT05446740. Inclusion in this directory is not an endorsement.