Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00383591
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2006-10-02
Brief Title:
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix-B in Pre- Haemodialysis Patients Aged 15 Years
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Clinical Trial Comparing the Persistence of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix-B at Months 24 30 36 in Pre-haemodialysisHaemodialysis Patients 15 Years of Age
Status:
COMPLETED
Status Verified Date:
2017-03
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:
Persistence of anti-HBs antibodies at Month 24 30 and 36 in subjects who had completed primary vaccination was evaluated The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres 10 mIUml at previous timepoint The study also evaluated the effect of a booster dose of the vaccine Month 42 after primary vaccination
Detailed Description:
None
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