Trials / Completed
CompletedNCT04071379
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose (Using Different Source of Hepatitis B), in Indonesian Infants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 0 Days – 3 Days
- Healthy volunteers
- Accepted
Summary
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B
Detailed description
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant Hepatitis B + DTP-HB-Hib | 1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib |
| BIOLOGICAL | Hep B + Pentabio (registered) | 1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered) |
Timeline
- Start date
- 2020-10-13
- Primary completion
- 2021-04-06
- Completion
- 2021-12-16
- First posted
- 2019-08-28
- Last updated
- 2022-01-18
Locations
3 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT04071379. Inclusion in this directory is not an endorsement.