Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492648
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2007-06-26
Brief Title:
Month 30 42 Extension Studies of CRD-004 Primary Study
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Extension Study to Evaluate the Persistence of the Immune Responses Induced by GSK Biologicals Zoster Vaccine GSK324332A Administered in Healthy Adult Subjects Aged 18-30 Years and 50-70 Years
Status:
COMPLETED
Status Verified Date:
2019-06
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:
The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study In the extension studies presented here the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine This protocol posting deals only with objectives outcome measures of the extension phase at Months 30 and 42 No new recruitment will be done in these extension phases of the primary study No vaccines are administered in this phase of the study
Detailed Description:
All subjects in these extension phases of the study were previously vaccinated with the investigational herpes zoster vaccine GSK1437173A The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Further details on the primary study can be found on our GSK study register httpswwwgsk-studyregistercomadvanced-search by searching on the GSK study identifier 101501
Further details on the primary study can be found on our GSK study register httpswwwgsk-studyregistercomadvanced-search by searching on the GSK study identifier 101501
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 |
|---|---|---|---|
| 109674 | None | None | None |