Trial · NCT00435812
Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
NCT00435812, Phase 3, Completed, Dynavax Technologies Corporation; results first posted 2018-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine. Trials, record NCT00435812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00435812
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
- NCT number
- NCT00435812
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,428 participants, actual
- Lead sponsor
- Dynavax Technologies Corporation
- Conditions
- Hepatitis B
- Interventions
- HEPLISAV and/or Placebo, Engerix-B
- First posted
- 2007-02-15
- Last updated
- 2019-03-20
- Other registries' IDs
- eudract:2006-006743-31
- Results first posted
- 2018-02-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Seroprotective Immune Response | Week 12 for HEPLISAV and Week 28 for Engerix-B | Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®) |
| Secondary | Percentage of Participants With Local and Systemic Reactions to Injections | Within 7 days post-injection for Post Injection Reactions |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Seroprotective Immune Response | Week 12 for HEPLISAV and Week 28 for Engerix-B | Per Protocol Population: Subjects who met eligibility criteria, did not violate the protocol in a substantial manner, received all protocol-specified study injections, had their primary serology and all injections within the specified day ranges, and had serology at their primary endpoint (Week 12 for HEPLISAV group and Week 28 for Engerix-B group) | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Local and Systemic Reactions to Injections | Within 7 days post-injection for Post Injection Reactions | Safety Analysis Population: All participants who received at least 1 study injection and had any post-baseline data. | Percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Seroprotective Immune Response | HEPLISAV and/or Placebo | 95.1 | Percentage of Participants | ||
| Percentage of Subjects With Seroprotective Immune Response | Engerix-B | 81.3 | Percentage of Participants | ||
| Percentage of Participants With Local and Systemic Reactions to Injections | HEPLISAV and/or Placebo | Local Reaction : Injection 1 | 40.4 | Percentage of subjects | |
| Percentage of Participants With Local and Systemic Reactions to Injections | Engerix-B | Local Reaction : Injection 1 | 34.1 | Percentage of subjects | |
| Percentage of Participants With Local and Systemic Reactions to Injections | HEPLISAV and/or Placebo | Local Reaction : Injection 2 | 35.8 | Percentage of subjects | |
| Percentage of Participants With Local and Systemic Reactions to Injections | Engerix-B | Local Reaction : Injection 2 | 24.8 | Percentage of subjects | |
| Percentage of Participants With Local and Systemic Reactions to Injections | HEPLISAV and/or Placebo | Local Reaction : Injection 3 | 6.5 | Percentage of subjects | |
| Percentage of Participants With Local and Systemic Reactions to Injections | Engerix-B | Local Reaction : Injection 3 | 20.5 | Percentage of subjects | |
| Percentage of Participants With Local and Systemic Reactions to Injections | HEPLISAV and/or Placebo | Systemic Reaction : Injection 1 | 27.1 | Percentage of subjects | |
| Percentage of Participants With Local and Systemic Reactions to Injections | Engerix-B | Systemic Reaction : Injection 1 | 29.2 | Percentage of subjects |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HEPLISAV and/or Placebo | 1,820 | |
| Overall Study | STARTED | Engerix-B | 608 | |
| Overall Study | COMPLETED | HEPLISAV and/or Placebo | 1,757 | |
| Overall Study | COMPLETED | Engerix-B | 590 | |
| Overall Study | NOT COMPLETED | HEPLISAV and/or Placebo | 63 | |
| Overall Study | NOT COMPLETED | Engerix-B | 18 |
Source ClinicalTrials.gov
Adverse events90
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 | Nasopharyngitis | Infections and infestations | HEPLISAV and/or Placebo | 303 | 1,821 | |
| other | Nasopharyngitis | Infections and infestations | Engerix-B | 100 | 607 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | HEPLISAV and/or Placebo | 94 | 1,821 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Engerix-B | 29 | 607 | |
| other | Headache | Nervous system disorders | HEPLISAV and/or Placebo | 205 | 1,821 | |
| other | Headache | Nervous system disorders | Engerix-B | 62 | 607 | |
| serious | Angina pectoris | Cardiac disorders | HEPLISAV and/or Placebo | 1 | 1,821 | |
| serious | Angina pectoris | Cardiac disorders | Engerix-B | 0 | 607 | |
| serious | Atrial fibrillation | Cardiac disorders | HEPLISAV and/or Placebo | 0 | 1,821 | |
| serious | Atrial fibrillation | Cardiac disorders | Engerix-B | 1 | 607 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HEPLISAV and/or Placebo | ||
| Total, all-cause mortality | Engerix-B | ||
| Total, other adverse events | HEPLISAV and/or Placebo | 602 | 1,821 |
| Total, other adverse events | Engerix-B | 191 | 607 |
| Total, serious adverse events | HEPLISAV and/or Placebo | 28 | 1,821 |
| Total, serious adverse events | Engerix-B | 13 | 607 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| HEPLISAV and/or Placebo vs Engerix-B: serious adverse events |
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/NCT00435812
GET https://conductscience.org/api/trials/v1/NCT00435812/events?page=2