Trials / Completed
CompletedNCT03408730
Lot-to-lot Consistency of Sci-B-Vac™ in Adults
A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,838 (actual)
- Sponsor
- VBI Vaccines Inc. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
Detailed description
The primary objective of the study is to verify that the manufacturing equivalence of Sci-B-Vac™ is consistent and to compare the immunogenicity and safety of a three-dose regimen of Sci-B-Vac™ to a three-dose regimen of Engerix-B® in adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Hepatitis B Vaccination | Hepatitis B Vaccination |
Timeline
- Start date
- 2017-12-14
- Primary completion
- 2019-10-01
- Completion
- 2019-10-01
- First posted
- 2018-01-24
- Last updated
- 2021-03-25
- Results posted
- 2020-10-14
Locations
26 sites across 6 countries: United States, Belgium, Canada, Finland, Germany, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03408730. Inclusion in this directory is not an endorsement.