Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04762511
Status:
TERMINATED
Last Update Posted:
2021-06-28
First Post:
2021-02-17
Brief Title:
A Study on the Reactogenicity Safety and Immune Response of a Vaccine Against Herpes Simplex Virus HSV-2 in Healthy Participants Aged 18-40 Years
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase I Single-blind Randomised Placebo-controlled Dose Escalation Study to Evaluate the Reactogenicity Safety and Immune Response of an HSV Vaccine in Healthy Participants Aged 18-40 Years
Status:
TERMINATED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
To enable development of an enhanced version of the vaccine
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 first-time-in-human FTiH study is to assess the reactogenicity safety and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 HSV-2 vaccine when administered intramuscularly IM on a 0 2-month schedule to healthy participants aged 18-40 years
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