At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,452 enrolled
Drug / intervention
HEPLISAV and/or Placebo +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Healthy Subjects 40 to 70 Years of Age
In Brief
A Phase 3 clinical trial evaluating HEPLISAV and/or Placebo and Engerix-B for Healthy. Completed, enrolled 2,452 participants across 32 sites in 2 countries.
Detailed Summary
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2009
Enrollment StartFeb 2010
Primary CompletionJan 2011
Study CompletionMay 2011
TodayJul 2026
First PostedNov 2, 2009
Enrollment StartFeb 1, 2010
Primary CompletionJan 1, 2011
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.7 years ago
Interventions
HEPLISAV and/or Placebobiological
Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
Engerix-Bbiological
Intramuscular (IM) injections on Week 0, Week 4 and Week 24