Trial · NCT03393754
Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
NCT03393754, Phase 3, Completed, VBI Vaccines Inc.; results first posted 2020-07-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults. Trials, record NCT03393754. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03393754
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
- NCT number
- NCT03393754
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,607 participants, actual
- Lead sponsor
- VBI Vaccines Inc.
- Conditions
- Hepatitis B Vaccines
- Interventions
- Hepatitis B Vaccination
- First posted
- 2018-01-08
- Last updated
- 2020-07-17
- Other registries' IDs
- eudract:2017-001819-36
- Results first posted
- 2020-07-07
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 18 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 | Day 196 | 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%. |
| Primary | Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 45 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 | Day 196 | To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is superior to the SPR 4 weeks after completion of the three-dose regimen of Engerix-B® in older adults ≥ 45 years old i.e. the lower bound of the 95% two-sided 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 receiving the third vaccination, will be \> 5%. |
| 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 | Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 18 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 | Day 196 | Per-protocol set - all subjects in the full analysis set who received all 3 injections, had at least baseline and 1 post-baseline immunogenicity assessment (at the time point of interest), were seronegative at baseline, and had no major protocol deviations leading to exclusion. | percentage of participants seroprotected | NUMBER |
| PRIMARY | Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 45 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 | Day 196 | Full analysis set - subjects who received at least 1 injection and had at least baseline and 1 post baseline immunogenicity assessment. | percentage of participants seroprotected | NUMBER |
| SECONDARY | Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Day of vaccine administration and six subsequent days | Safety set: all subjects in the All Enrolled Set who received at least 1 injection | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 18 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 | Engerix-B® Hepatitis B Vaccination | 76.49 | 95% Confidence Interval 73.22 to 79.53 | percentage of participants seroprotected | |
| Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 18 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 | Sci-B-Vac® Hepatitis B Vaccination | 91.36 | 95% Confidence Interval 89.07 to 93.32 | percentage of participants seroprotected | |
| Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 45 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 | Engerix-B® Hepatitis B Vaccination | 73.05 | 95% Confidence Interval 69.39 to 76.48 | percentage of participants seroprotected | |
| Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 45 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 | Sci-B-Vac® Hepatitis B Vaccination | 89.44 | 95% Confidence Interval 86.76 to 91.74 | percentage of participants seroprotected | |
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Engerix-B® Hepatitis B Vaccination | Pain | 294 | Participants | |
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Sci-B-Vac® Hepatitis B Vaccination | Pain | 503 | Participants | |
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Engerix-B® Hepatitis B Vaccination | Tenderness | 282 | Participants | |
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Sci-B-Vac® Hepatitis B Vaccination | Tenderness | 484 | Participants | |
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Engerix-B® Hepatitis B Vaccination | Pruritus/itching | 66 | Participants | |
| Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) | Sci-B-Vac® Hepatitis B Vaccination | Pruritus/itching | 76 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Engerix-B® Hepatitis B Vaccination | 811 | |
| Overall Study | STARTED | Sci-B-Vac® Hepatitis B Vaccination | 796 | |
| Overall Study | COMPLETED | Engerix-B® Hepatitis B Vaccination | 785 | |
| Overall Study | COMPLETED | Sci-B-Vac® Hepatitis B Vaccination | 758 | |
| Overall Study | NOT COMPLETED | Engerix-B® Hepatitis B Vaccination | 26 | |
| Overall Study | NOT COMPLETED | Sci-B-Vac® Hepatitis B Vaccination | 38 |
Source ClinicalTrials.gov
Adverse events152
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 | Diarrhoea | Gastrointestinal disorders | Engerix-B® Hepatitis B Vaccination | 21 | 811 | |
| other | Diarrhoea | Gastrointestinal disorders | Sci-B-Vac® Hepatitis B Vaccination | 12 | 796 | |
| other | Toothache | Gastrointestinal disorders | Engerix-B® Hepatitis B Vaccination | 10 | 811 | |
| other | Toothache | Gastrointestinal disorders | Sci-B-Vac® Hepatitis B Vaccination | 5 | 796 | |
| other | Nausea | Gastrointestinal disorders | Engerix-B® Hepatitis B Vaccination | 10 | 811 | |
| other | Nausea | Gastrointestinal disorders | Sci-B-Vac® Hepatitis B Vaccination | 3 | 796 | |
| other | Fatigue | General disorders | Engerix-B® Hepatitis B Vaccination | 40 | 811 | |
| other | Fatigue | General disorders | Sci-B-Vac® Hepatitis B Vaccination | 34 | 796 | |
| other | Injection site pain | General disorders | Engerix-B® Hepatitis B Vaccination | 13 | 811 | |
| other | Injection site pain | General disorders | Sci-B-Vac® Hepatitis B Vaccination | 23 | 796 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Engerix-B® Hepatitis B Vaccination | 0 | 811 |
| Total, all-cause mortality | Sci-B-Vac® Hepatitis B Vaccination | 0 | 796 |
| Total, other adverse events | Engerix-B® Hepatitis B Vaccination | 455 | 811 |
| Total, other adverse events | Sci-B-Vac® Hepatitis B Vaccination | 429 | 796 |
| Total, serious adverse events | Engerix-B® Hepatitis B Vaccination | 21 | 811 |
| Total, serious adverse events | Sci-B-Vac® Hepatitis B Vaccination | 32 | 796 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Engerix-B® Hepatitis B Vaccination vs Sci-B-Vac® Hepatitis B Vaccination: deaths from any cause | Trial comparisons |
| Engerix-B® Hepatitis B Vaccination vs Sci-B-Vac® Hepatitis B Vaccination: serious adverse events | 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/NCT03393754
GET https://conductscience.org/api/trials/v1/NCT03393754/results?page=2