A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
NCT05446740 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 324
Last updated 2026-03-10
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
- Influenza, Human
Interventions
- 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
Sponsors & Collaborators
-
CureVac
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-08-09
- Primary Completion
- 2024-03-26
- Completion
- 2024-03-26
Countries
- Belgium
- Canada
- Spain
Study Locations
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