Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435812
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2007-02-13
Brief Title:
Safety and Efficacy of HEPLISAV Hepatitis B Virus Vaccine Compared With Engerix-B Vaccine
Sponsor:
Dynavax Technologies Corporation
Organization:
Dynavax Technologies Corporation
Study Overview
Official Title:
A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV or Three Doses of Engerix-B
Status:
COMPLETED
Status Verified Date:
2019-03
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:
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine HEPLISAV is safe and effective compared with Engerix-B vaccine in subjects 11-55 years old The primary hypothesis is that the seroprotective immune response of HEPLISAV is at least as good as that of Engerix-B
Detailed Description:
This study will evaluate the safety and efficacy of two injections of HEPLISAV compared with three injections of a commercially available hepatitis B virus HBV vaccine Engerix-B in subjects 11 to 55 years old About 2400 subjects will be included in the study Once subjects are consented screened and randomized to treatment all subjects will receive a total of three injections over a 24-week period with a follow-up visit at 28 weeks Subjects randomized to Engerix-B will receive 3 injections of active vaccine while subjects randomized to HEPLISAV will receive 2 injections of active vaccine plus 1 injection of placebo Safety and tolerability will be evaluated by occurrence of adverse events periodic laboratory tests vital signs and localsystemic reactogenicity
Comparison Subjects will receive treatment with either HEPLISAV or the comparator vaccine Engerix-B
Comparison Subjects will receive treatment with either HEPLISAV or the comparator vaccine Engerix-B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2006-006743-31 | EUDRACT_NUMBER | None | None |