Status:
COMPLETED
Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
Lead Sponsor:
Dynavax Technologies Corporation
Conditions:
Hepatitis B
Eligibility:
All Genders
11-55 years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- Willing and able to give written informed consent
- Is serum negative for HBV antibodies
Exclusion
- Women who are pregnant or breastfeeding
- Any previous HBV infection
- Previous vaccination with any HBV vaccine (1 or more doses)
- Any autoimmune disease
- Received any blood products or antibodies within 3 months prior to study entry
- Ever received an injection with DNA plasmids or oligonucleotides
- Received any vaccines within 4 weeks prior to study entry
- Received any other investigational medicinal agent within 4 weeks prior to study entry
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
2428 Patients enrolled
Trial Details
Trial ID
NCT00435812
Start Date
December 1 2006
End Date
March 1 2008
Last Update
March 20 2019
Active Locations (18)
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1
Edmonton, Alberta, Canada
2
Surrey, British Columbia, Canada
3
Winnipeg, Manitoba, Canada
4
Mount Pearl, Newfoundland and Labrador, Canada