Trials / Completed
CompletedNCT03919578
Protectivity and Safety Following Recombinant Hepatitis B Vaccine
Protectivity and Safety Following Recombinant Hepatitis B Vaccine With Different Source of Hepatitis B Bulk Compared to Hepatitis B (Bio Farma) Vaccine in Indonesian Population
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 536 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 10 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population
Detailed description
Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population. Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant Hepatitis B vaccine | Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma. |
| BIOLOGICAL | Recombinant Hepatitis B (Bio Farma) | Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from The Janssen Vaccine Corp and then formulated and filled at Bio Farma. |
Timeline
- Start date
- 2019-09-11
- Primary completion
- 2020-01-30
- Completion
- 2020-02-28
- First posted
- 2019-04-18
- Last updated
- 2022-09-19
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT03919578. Inclusion in this directory is not an endorsement.