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NCT03393754 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
A Phase 3 study, sponsored by VBI Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,607
- Enrollment target
NCT03393754: Completed Phase 3 study, sponsored by VBI Vaccines.
NCT03393754 is a Phase 3 study that has completed, run by VBI Vaccines. The registered enrollment target is 1,607 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (108% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03393754, a Phase 3 study, has completed, sponsored by VBI Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,607 participants
- Enrollment target
Study 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.
Primary Outcome
To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is non-inferior to a three-dose regimen of Engerix-B® in adults ≥18 years old; i.e. the lower bound of the 95% two-sided confidence interval (CI) of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after the third vaccination, will be \> - 5%.
Interventions
- BIOLOGICAL Hepatitis B Vaccination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,607 participants |
| Start Date | 2017-12-13 |
| Est. Completion | 2019-04-08 |
| Phase | Phase 3 |
What the finished NCT03393754 record still lists
NCT03393754 is an interventional study that assigns participants to a tested intervention. Its 1,607 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (108% higher).
The record links to 0 conditions, and to 1 intervention - of which Hepatitis B Vaccination is the first listed.
NCT03393754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03393754 about?
NCT03393754 is a clinical study titled "Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults". 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.
What is the current status of trial NCT03393754?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,607 participants. The study started on 2017-12-13. Estimated completion is 2019-04-08.
What interventions are being tested in trial NCT03393754?
The interventions under investigation include: Hepatitis B Vaccination (BIOLOGICAL).
Who is sponsoring clinical trial NCT03393754?
This trial is sponsored by VBI Vaccines, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03393754's enrollment target sits among peer trials
1,607 142nd of 2000 higher than 1,859 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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