Trials / Withdrawn
WithdrawnNCT05482282
Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)
Comparison of Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose Using New Hepatitis B Bulk (Bio Farma), in Indonesian Infants
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 1 Day – 3 Days
- Healthy volunteers
- Accepted
Summary
This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).
Detailed description
This bridging study is a randomized, double blind, two arms parallel groups, prospective intervention study. Total 220 infants, 0-3 days old will be involved in this study. The subject will be divided into 2 groups, 110 subjects are the investigational group and 110 subjects are the active comparator group. The objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma) and to asses the safety of DTP-HB-Hib Vaccine (Bio Farma) and Recombinant Hepatitis B Vaccine using new Hepatitis B bulk (Bio Farma).
Conditions
- Diphtheria Vaccine Adverse Reaction
- Tetanus Vaccine Adverse Reaction
- Pertussis Vaccine Adverse Reaction
- Haemophilus Influenzae Type B Vaccine Adverse Reaction
- Hepatitis B Vaccine Adverse Reaction
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant Hepatitis B new Bulk vaccine | 1 dose of Recombinant Hepatitis B vaccine using new Hepatitis B bulk (Bio Farma) 1 dose of 0.5 ml Recombinant Hepatitis B new Bulk vaccine dose of DTP-HB-Hib using new Hepatitis B Bulk vaccine injected intramuscularly into the left external antero-lateral thigh region. |
| BIOLOGICAL | DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine | 3 doses of DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine |
| BIOLOGICAL | Recombinant Hepatitis B vaccine (Registered BioFarma) | 1 dose of Recombinant Hepatitis B vaccine (Registered Bio Farma) |
| BIOLOGICAL | Pentabio | 3 doses of Pentabio |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2022-08-01
- Last updated
- 2025-06-05
Locations
3 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT05482282. Inclusion in this directory is not an endorsement.