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NCT03408730 · ClinicalTrials.gov registry record · Phase 3
Lot-to-lot Consistency of Sci-B-Vac™ in Adults
A Phase 3 study, sponsored by VBI Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,838
- Enrollment target
NCT03408730: Completed Phase 3 study, sponsored by VBI Vaccines.
NCT03408730 is a Phase 3 study that has completed, run by VBI Vaccines. The registered enrollment target is 2,838 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (268% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03408730, a Phase 3 study, has completed, sponsored by VBI Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,838 participants
- Enrollment target
Study Summary
A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
Primary Outcome
To demonstrate the manufacturing equivalence, in terms of immunogenicity, as measured by GMC of antibodies, of 3 independent consecutive lots of the Sci-B-Vac® 4 weeks after the third vaccination. Lot-to-lot manufacturing consistency of Sci-B-Vac® is demonstrated if the 95% CIs of the adjusted anti-HBs GMC ratios between lots are within the pre-specified range of \[0.67, 1.5\].
Interventions
- BIOLOGICAL Hepatitis B Vaccination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,838 participants |
| Start Date | 2017-12-14 |
| Est. Completion | 2019-10-01 |
| Phase | Phase 3 |
What the finished NCT03408730 record still lists
NCT03408730 is an interventional study that assigns participants to a tested intervention. Its 2,838 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 (268% higher).
The record links to 0 conditions, and to 1 intervention - of which Hepatitis B Vaccination is the first listed.
NCT03408730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03408730 about?
NCT03408730 is a clinical study titled "Lot-to-lot Consistency of Sci-B-Vac™ in Adults". A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
What is the current status of trial NCT03408730?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,838 participants. The study started on 2017-12-14. Estimated completion is 2019-10-01.
What interventions are being tested in trial NCT03408730?
The interventions under investigation include: Hepatitis B Vaccination (BIOLOGICAL).
Who is sponsoring clinical trial NCT03408730?
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 NCT03408730's enrollment target sits among peer trials
2,838 81st of 2000 higher than 1,920 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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