drugset / Trial / NCT05482282
Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)
RandomizedParallel-groupDouble-blindPrevention
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).
Timeline
- Start
- 2025-12
- Primary completion
- 2026-12
- Completion
- 2026-12
Outcome
Outcome not reported
Stopped: “The products will be replace with others.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine | Vaccine | — | — |
| Comparator | Pentabio | Vaccine | — | — |
| Subject | Recombinant Hepatitis B new Bulk vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Recombinant Hepatitis B vaccine (Registered BioFarma) | Vaccine | — | — |