Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT01767467
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2013-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2018-05
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 evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.
Detailed Description:
Amendment to protocol posting:
Increase in sample size, update of country/region-specific information (Sections 5, 6 and 9).
Promotion of secondary to primary objective; related update of primary and secondary outcome measures (Sections 4 and 7).
Increase in sample size, update of country/region-specific information (Sections 5, 6 and 9).
Promotion of secondary to primary objective; related update of primary and secondary outcome measures (Sections 4 and 7).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-003438-18 | EUDRACT_NUMBER | None | View |