Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-01 @ 1:44 AM
Study NCT ID:
NCT01777295
Status:
COMPLETED
Last Update Posted:
2019-01-04
First Post:
2013-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Development of Read-outs to Detect and Characterise the Early and Adaptive Immune Responses in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen in Combination With a GSK Biologicals' Adjuvant System
Status:
COMPLETED
Status Verified Date:
2018-06
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:
This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines.
This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals' Adjuvant System.
This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals' Adjuvant System.
Detailed Description:
This study will be conducted in 2 steps with 2 study groups in each step. The entire study period for Step 1 is from Day -30 to Day 210 (240 days) The entire study period for Step 2 is from Day 0 to Day 180 for Group C and from Day 0 to Day 330 for Group D.
Subjects will be blinded up to Day 60 in Step 1 and will be unblinded at the end of their Day 60 visit. Step 2 will be conducted in an open-label manner.
Subjects will be blinded up to Day 60 in Step 1 and will be unblinded at the end of their Day 60 visit. Step 2 will be conducted in an open-label manner.
Study Oversight
Has Oversight DMC:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-001344-22 | EUDRACT_NUMBER | None | View |