Trials / Completed
CompletedNCT05568797
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above
A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV (Inactivated Influenza Vaccine - Adjuvanted) in Adults Aged 65 Years and Above
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,045 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSVPreF3 OA vaccine | One dose of RSVPreF3 OA vaccine administered intramuscularly. |
| BIOLOGICAL | FLU vaccine | One dose of FLU vaccine administered intramuscularly. |
Timeline
- Start date
- 2022-10-14
- Primary completion
- 2023-02-17
- Completion
- 2023-07-17
- First posted
- 2022-10-06
- Last updated
- 2024-09-24
- Results posted
- 2024-03-15
Locations
37 sites across 5 countries: Belgium, Finland, France, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05568797. Inclusion in this directory is not an endorsement.