Trials / Completed
CompletedNCT03393754
Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
A Phase 3 Double-Blind Randomized Controlled Trial 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 (PROTECT)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,607 (actual)
- Sponsor
- VBI Vaccines Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in ≥ 45 years old.
Detailed description
This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 45 years old. Study subjects are randomized 1:1 to receive either a total of 3 injections of Sci-B-Vac® or 3 injections of Engerix-B® intra-muscularly (IM) on Days 0, 28, and 168.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Hepatitis B Vaccination | Prophylactic Hepatitis B Vaccination |
Timeline
- Start date
- 2017-12-13
- Primary completion
- 2019-04-08
- Completion
- 2019-04-08
- First posted
- 2018-01-08
- Last updated
- 2020-07-17
- Results posted
- 2020-07-07
Locations
28 sites across 4 countries: United States, Belgium, Canada, Finland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03393754. Inclusion in this directory is not an endorsement.