Trials / Terminated
TerminatedNCT01311674
Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
Hepatitis B Virus (HBV) Antibody (Anti-HBs) Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- Emergent BioSolutions · Industry
- Sex
- All
- Age
- 20 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Hepatitis B Virus Antibody Booster Program
Detailed description
The purpose of this study is to vaccinate plasmapheresis donors for collection of high titer plasma to be used in the manufacture of Hepatitis B Immune Globulin (HBIG).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | hepatitis B vaccine | Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL |
| BIOLOGICAL | hepatitis B vaccine | Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2011-03-11
- Completion
- 2011-03-11
- First posted
- 2011-03-09
- Last updated
- 2024-03-18
- Results posted
- 2021-08-17
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01311674. Inclusion in this directory is not an endorsement.