Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434577
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2007-02-12
Brief Title:
Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase II Single-blind Randomized Controlled Multicentre Vaccination Study to Evaluate the Safety and Immune Response of the GSK Biologicals Zoster Vaccine gEAS01B and to Compare 3 Doses of gE With AS01B Adjuvant in Healthy Elderly Subjects Aged 60 to 69 Years and 70 Years and Above
Status:
COMPLETED
Status Verified Date:
2019-02
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:
Based on the results of a previous clinical PhaseIII study GSK1437173A is the lead GSK candidate Herpes Zoster HZ vaccine to prevent episodes of HZ shingles This phase II study will be subdivided into a primary study 108494 and three extension studies 108516 108518 108520 consisting of one additional visit each at months 12 24 and 36 respectively from the first visit of the Zoster-003 primary study onwards The aim of the primary 108494 study is to evaluate the immunogenicity safety of different dosages of the GSK1437173A vaccine in healthy elderly population The study population will be stratified by age The primary objective of this trial is to select the best dosage of GSK1437173A The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period
No new subjects will be enrolled during the extension phases of the study
No new subjects will be enrolled during the extension phases of the study
Detailed Description:
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-004863-69 | EUDRACT_NUMBER | GSK | None |
| 108516 | OTHER | None | None |
| 108518 | OTHER | None | None |
| 108520 | OTHER | None | None |