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NCT02117934 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
A Phase 3 study of Healthy, sponsored by Dynavax Technologies Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 8,374
- Enrollment target
- 20
- Study locations
NCT02117934: Completed Phase 3 study of Healthy, sponsored by Dynavax Technologies Corporation.
NCT02117934 is a Phase 3 study of Healthy that has completed, run by Dynavax Technologies Corporation. The registered enrollment target is 8,374 participants, above the 640-participant average among 1,090 other Healthy trials with a reported enrollment target (1208% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02117934, a Phase 3 study of Healthy, has completed, sponsored by Dynavax Technologies Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 8,374 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.
Primary Outcome
The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.
Conditions Studied
Interventions
- BIOLOGICAL Engerix-B
- BIOLOGICAL HEPLISAV
Study Locations (20)
Arizona
- Clinical Research Advantage, Inc. - Chandler
- Radiant Research - Chandler
- Clinical Research Advantage, Inc. - Glendale
- Clinical Research Advantage, Inc. - Mesa
- Clinical Research Advantage, Inc. - Mesa
- Clinical Research Advantage, Inc. - Phoenix
- Clinical Research Advantage, Inc. - Phoenix
- Clinical Research Advantage, Inc. - Phoenix
- Radiant Research - Scottsdale
- Clinical Research Advantage, Inc. - Tempe
- Radiant Research - Tucson
- Clinical Research Advantage, Inc. - Tucson
Colorado
- Clinical Research Advantage, Inc. - Centennial
- Clinical Research Advantage, Inc. - Colorado Springs
- Radiant Research - Denver
California
- Radiant Research - Santa Rosa
- Clinical Research Advantage, Inc. - Vista
Alabama
- Clinical Research Advantage, Inc. - Birmingham
Florida
- Radiant Research - Pinellas Park
Georgia
- Radiant Research - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,374 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
What the finished NCT02117934 record still lists
NCT02117934 is an interventional study that assigns participants to a tested intervention. Its 8,374 participants enrollment target places it among the larger protocols in the corpus, above the 640-participant average among 1,090 other Healthy trials with a reported enrollment target (1208% higher).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Engerix-B is the first listed.
NCT02117934 names 20 study sites across 6 states, led by Arizona, Colorado, California.
Frequently Asked Questions
What is clinical trial NCT02117934 about?
NCT02117934 is a clinical study titled "Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine". The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.
What is the current status of trial NCT02117934?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 8,374 participants. The study started on 2014-04. Estimated completion is 2015-10.
What conditions does trial NCT02117934 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02117934?
The interventions under investigation include: Engerix-B (BIOLOGICAL), HEPLISAV (BIOLOGICAL).
Who is sponsoring clinical trial NCT02117934?
This trial is sponsored by Dynavax Technologies Corporation, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02117934 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02117934's enrollment target sits among peer trials
8,374 9th of 1090 higher than 1,082 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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