Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374394
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-16
Brief Title:
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus RSV When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase 3 Open-label Randomized Controlled Study to Evaluate the Immune Response Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With a COVID-19 mRNA Vaccine Omicron XBB15 in Adults Aged 50 Years and Above
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess the immunogenicity safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid mRNA vaccine Omicron XBB15 compared to administration of the vaccines separately in adults aged 50 years and above
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-510196-59-00 | OTHER | EU CTR Number | None |