Trial · NCT03408730
Lot-to-lot Consistency of Sci-B-Vac™ in Adults
NCT03408730, Phase 3, Completed, VBI Vaccines Inc.; results first posted 2020-10-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lot-to-lot Consistency of Sci-B-Vac™ in Adults. Trials, record NCT03408730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03408730
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lot-to-lot Consistency of Sci-B-Vac™ in Adults
- NCT number
- NCT03408730
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,838 participants, actual
- Lead sponsor
- VBI Vaccines Inc.
- Conditions
- Hepatitis B Vaccines
- Interventions
- Hepatitis B Vaccination
- First posted
- 2018-01-24
- Last updated
- 2021-03-25
- Other registries' IDs
- eudract:2017-001820-22
- Results first posted
- 2020-10-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1) | 4 weeks after third vaccination (Study Day 196) | 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 \[0.67, 1.5\]. |
| Secondary | Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2) | 4 weeks after third vaccination (Study Day 196) | The difference in proportions \[SPR(Sci-B-Vac®)-SPR(Engerix-B®)\] and two-sided 95% CIs were summarized. If the lower bound of the 95% CI was \> 5%, Sci-B-Vac® was to be declared non-inferior to Engerix-B® |
| Secondary | Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Day of vaccine administration and six subsequent days | Analysis of local and systemic solicited adverse events with an interval of onset of Day 1 to Day 7 after any vaccination with either Sci-B-Vac® or Engerix-B®, in adults ≥18 years old. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1) | 4 weeks after third vaccination (Study Day 196) | Per Protocol Set 1 included all subjects in the full analysis set who received all 3 vaccinations, had an evaluable serum immunogenicity samples at baseline and at the time point of interest, were seronegative at baseline, and had no major protocol violations leading to exclusion | mIU/ml | MEAN |
| SECONDARY | Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2) | 4 weeks after third vaccination (Study Day 196) | Per Protocol Set 2 included all subjects in Per Protocol Set 1 excluding subjects who attended visits outside of windows including Visit 3/Day 168 (±28 days) and Visit 44/Day 196 (-7/+14 days) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Day of vaccine administration and six subsequent days | Safety Set included all subjects in the All Enrolled Set who received at least 1 vaccination | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1) | Sci-B-Vac Lot A Hep B Vaccination | 5883.93 | Standard Deviation 5.423 | mIU/ml | |
| Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1) | Sci-B-Vac Lot B Hep B Vaccination | 4824.06 | Standard Deviation 6.293 | mIU/ml | |
| Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1) | Sci-B-Vac Lot C Hep B Vaccination | 5505.98 | Standard Deviation 5.975 | mIU/ml | |
| Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2) | Comparator: ENGERIX-B Hep B Vaccination | 561 | Participants | ||
| Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2) | Pooled Sci-B-Vac® | 1740 | Participants | ||
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Comparator: ENGERIX-B Hep B Vaccination | Pain | 384 | Participants | |
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Sci-B-Vac Lot A Hep B Vaccination | Pain | 527 | Participants | |
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Sci-B-Vac Lot B Hep B Vaccination | Pain | 536 | Participants | |
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Sci-B-Vac Lot C Hep B Vaccination | Pain | 542 | Participants | |
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Comparator: ENGERIX-B Hep B Vaccination | Tenderness | 391 | Participants |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Comparator: ENGERIX-B Hep B Vaccination | 712 | |
| Overall Study | STARTED | Sci-B-Vac Lot A Hep B Vaccination | 711 | |
| Overall Study | STARTED | Sci-B-Vac Lot B Hep B Vaccination | 709 | |
| Overall Study | STARTED | Sci-B-Vac Lot C Hep B Vaccination | 706 | |
| Overall Study | COMPLETED | Comparator: ENGERIX-B Hep B Vaccination | 643 | |
| Overall Study | COMPLETED | Sci-B-Vac Lot A Hep B Vaccination | 636 | |
| Overall Study | COMPLETED | Sci-B-Vac Lot B Hep B Vaccination | 637 | |
| Overall Study | COMPLETED | Sci-B-Vac Lot C Hep B Vaccination | 625 | |
| Overall Study | NOT COMPLETED | Comparator: ENGERIX-B Hep B Vaccination | 69 | |
| Overall Study | NOT COMPLETED | Sci-B-Vac Lot A Hep B Vaccination | 75 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events292
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Comparator: ENGERIX-B Hep B Vaccination | 68 | 712 | |
| other | Upper respiratory tract infection | Infections and infestations | Sci-B-Vac Lot A Hep B Vaccination | 68 | 711 | |
| other | Upper respiratory tract infection | Infections and infestations | Sci-B-Vac Lot B Hep B Vaccination | 77 | 708 | |
| other | Upper respiratory tract infection | Infections and infestations | Sci-B-Vac Lot C Hep B Vaccination | 77 | 705 | |
| other | Nasopharyngitis | Infections and infestations | Comparator: ENGERIX-B Hep B Vaccination | 55 | 712 | |
| other | Nasopharyngitis | Infections and infestations | Sci-B-Vac Lot A Hep B Vaccination | 39 | 711 | |
| other | Nasopharyngitis | Infections and infestations | Sci-B-Vac Lot B Hep B Vaccination | 42 | 708 | |
| other | Nasopharyngitis | Infections and infestations | Sci-B-Vac Lot C Hep B Vaccination | 53 | 705 | |
| other | Influenza | Infections and infestations | Comparator: ENGERIX-B Hep B Vaccination | 19 | 712 | |
| other | Influenza | Infections and infestations | Sci-B-Vac Lot A Hep B Vaccination | 15 | 711 |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Comparator: ENGERIX-B Hep B Vaccination | 0 | 712 |
| Total, all-cause mortality | Sci-B-Vac Lot A Hep B Vaccination | 1 | 711 |
| Total, all-cause mortality | Sci-B-Vac Lot B Hep B Vaccination | 0 | 708 |
| Total, all-cause mortality | Sci-B-Vac Lot C Hep B Vaccination | 0 | 705 |
| Total, other adverse events | Comparator: ENGERIX-B Hep B Vaccination | 381 | 712 |
| Total, other adverse events | Sci-B-Vac Lot A Hep B Vaccination | 376 | 711 |
| Total, other adverse events | Sci-B-Vac Lot B Hep B Vaccination | 392 | 708 |
| Total, other adverse events | Sci-B-Vac Lot C Hep B Vaccination | 399 | 705 |
| Total, serious adverse events | Comparator: ENGERIX-B Hep B Vaccination | 3 | 712 |
| Total, serious adverse events | Sci-B-Vac Lot A Hep B Vaccination | 12 | 711 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34636914 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Comparator: ENGERIX-B Hep B Vaccination vs Pooled Sci-B-Vac®: Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03408730
GET https://conductscience.org/api/trials/v1/NCT03408730/results?page=2