Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758962
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2021-02-08
Brief Title:
A Study of the Safety of and Immune Response to Varying Doses of a Vaccine Against COVID-19 in Healthy Adults
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase I First-Time-in Human FTiH Open-label Dose Escalation Non-randomized Study to Assess Safety Reactogenicity and Immune Response of a CoV-2 SAM LNP Vaccine When Administered Intramuscularly on a 0 1 Month Schedule in Healthy Adults 18 to 50 Years of Age
Status:
COMPLETED
Status Verified Date:
2024-01
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 assess the safety reactogenicity and immune response of a self-amplifying mRNA SAM lipid nanoparticle LNP platform with severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 Spike antigen CoV-2 SAM LNP vaccine in ascending doses when administered intramuscularly IM on a 01-month schedule to healthy adults 18 to 50 years of age There will be no administration of escalated doses of the study vaccine
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