Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-01 @ 8:38 PM
Study NCT ID:
NCT01053767
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2010-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Persistence of Two GBS Antibodies in Women Previously Immunized With a GBS Vaccine
Sponsor:
Novartis Vaccines
Organization:
Study Overview
Official Title:
A Phase I Extension Study to Assess the Long-Term Persistence of GBS Serotypes Ib and III Antibodies in Women Previously Immunized With a GBS Ib and III Crm-Glycoconjugate Vaccine
Status:
COMPLETED
Status Verified Date:
2011-12
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 looks at the body's immune response to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P2 study. Blood will be drawn and evaluated for GBS antibody levels.
Detailed Description:
None
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?: