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Drug intelligence / Profile preview
recombinant hepatitis B vaccine + DTP-HB-Hib vaccine
- Development stage
- Unknown
- Lead developer
- Bio Farma
- Modality
- Vaccines & Immunotherapeutics
- Administration
- Intramuscular
01
Overview
Recombinant Hepatitis B + DTP-HB-Hib is a combination vaccine regimen developed by PT Bio Farma (Indonesia) for the prevention of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b (Hib) infections in infants. The regimen consists of a birth dose of recombinant Hepatitis B vaccine (produced in the yeast Hansenula polymorpha) followed by a three-dose primary series of a pentavalent DTP-HB-Hib vaccine. The pentavalent component, marketed under the brand name Pentabio, contains diphtheria and tetanus toxoids, inactivated whole-cell pertussis bacteria, recombinant Hepatitis B surface antigen (HBsAg), and Hib conjugate. A Phase 3 bridging study (NCT04071379) completed in 2021 demonstrated that a new batch of the DTP-HB-Hib vaccine was immunogenic and well-tolerated in Indonesian infants when used in this priming regimen.
- Brand names
- Pentabio
- Other names
- DTP-HB-Hib (Bio Farma)pentavalent vaccine
02
Targets
Diphtheria toxinPRNP (Cellular Prion Protein)HBsAg (Hepatitis B surface antigen)TT (Tetanus toxoid)
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