A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
NCT05823974 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1275
Last updated 2025-07-23
Summary
The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA).
Conditions
- Influenza, Human
Interventions
- BIOLOGICAL
-
F2C22C/DL001Z
Study intervention was administered intramuscularly in Phase 1, at Day 1.
- BIOLOGICAL
-
F2B22A/DL001Z
Study intervention was administered intramuscularly in Phase 1, at Day 1.
- BIOLOGICAL
-
F2B22B/DL001Z
Study intervention was administered intramuscularly in Phase 1, at Day 1.
- BIOLOGICAL
-
F2B22C/DL001Z
Study intervention was administered intramuscularly in Phase 1, at Day 1.
- BIOLOGICAL
-
F2B22D/DL001Z
Study intervention was administered intramuscularly in Phase 1, at Day 1.
- BIOLOGICAL
-
F2B22E/DL001Z
Study intervention was administered intramuscularly in Phase 1, at Day 1.
- BIOLOGICAL
-
F2F22A/DL001Z
Study intervention was administered intramuscularly in Phase 1, at Day 1.
- BIOLOGICAL
-
F2F22B/DL001Z
Study intervention was administered intramuscularly in Phase 1, at Day 1.
- BIOLOGICAL
-
F2F22C/DL001Z
Study intervention was administered intramuscularly in Phase 1, at Day 1.
- BIOLOGICAL
-
F2F22D/DL001Z
Study intervention was administered intramuscularly in Phase 1, at Day 1.
- BIOLOGICAL
-
F2F22E/DL001Z
Study intervention was administered intramuscularly in Phase 1, at Day 1.
- COMBINATION_PRODUCT
-
Control 1
Control vaccine was administered intramuscularly in Phase 1, at Day 1.
- BIOLOGICAL
-
F2F23D/DL001Z-NH
Study intervention was administered intramuscularly in Phase 2, at Day 1.
- BIOLOGICAL
-
F2F23A/DL001Z-NH
Study intervention was administered intramuscularly in Phase 2, at Day 1.
- BIOLOGICAL
-
F2F23B/DL001Z-NH
Study intervention was administered intramuscularly in Phase 2, at Day 1.
- COMBINATION_PRODUCT
-
Control 2
Control vaccine was administered intramuscularly in Phase 2, at Day 1.
- BIOLOGICAL
-
F2F23C/DL001Z-NH
Study intervention was administered intramuscularly in Phase 2, at Day 1.
- COMBINATION_PRODUCT
-
Control 3
Control vaccine was administered intramuscularly in Phase 2, at Day 1.
- BIOLOGICAL
-
F2F22F/DL001Z
Study intervention was administered intramuscularly in Phase 1, 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
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-04-27
- Primary Completion
- 2024-07-02
- Completion
- 2024-12-18
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Canada
- South Africa
Study Locations
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