Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-03 @ 2:31 AM
Study NCT ID:
NCT04090658
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2019-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Phase I, Observer-blind, Safety, Reactogenicity and Immunogenicity Study of GSK's Respiratory Syncytial Virus (RSV) Vaccine GSK3844766A in Japanese Subjects Aged 60-80 Years
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 doses of GSK Biologicals' RSV candidate vaccine adjuvanted with AS01B for the prevention of lower respiratory tract diseases caused by RSV in ethnic Japanese adults 60-80 years of age.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: