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Recombinant Hepatitis B + DTP-HB-Hib
This combination vaccine provides immunization against hepatitis B, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b by stimulating the immune system to produce protective antibodies against these pathogens.
This combination vaccine provides immunization against hepatitis B, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b by stimulating the immune system to produce protective antibodies against these pathogens. Used for Prevention of hepatitis B infection, Prevention of diphtheria, Prevention of tetanus.
At a glance
| Generic name | Recombinant Hepatitis B + DTP-HB-Hib |
|---|---|
| Also known as | Hep B + DTP-HB-Hib |
| Sponsor | PT Bio Farma |
| Drug class | Combination vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains recombinant hepatitis B surface antigen along with inactivated toxoids and antigens from diphtheria, tetanus, and pertussis bacteria, plus Haemophilus influenzae type b polysaccharide conjugate. Upon administration, these antigens trigger both humoral and cellular immune responses, leading to the production of specific antibodies and memory cells that protect against infection with these five pathogens.
Approved indications
- Prevention of hepatitis B infection
- Prevention of diphtheria
- Prevention of tetanus
- Prevention of pertussis (whooping cough)
- Prevention of Haemophilus influenzae type b infection
Common side effects
- Injection site pain, redness, or swelling
- Fever
- Irritability or fussiness
- Drowsiness
Key clinical trials
- Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) (PHASE3)
- Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Recombinant Hepatitis B + DTP-HB-Hib CI brief — competitive landscape report
- Recombinant Hepatitis B + DTP-HB-Hib updates RSS · CI watch RSS
- PT Bio Farma portfolio CI