Clinical trials: Hepatitis B Vaccine Adverse Reaction
Vaccine Adverse Reaction, Vaccine Reaction
Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study.
- Trial name
- NCT06690515
- Testing
- DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A, DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B, Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®
- Where
- 3 sites in Indonesia
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction
Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)
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…
- Conditions
- Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse Reaction, Haemophilus Influenzae Type B Vaccine Adverse Reaction
- Trial name
- NCT05482282
- Testing
- Recombinant Hepatitis B new Bulk vaccine, DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine, Recombinant Hepatitis B vaccine (Registered BioFarma)
- Where
- 3 sites in Indonesia
- Volunteers
- healthy volunteers welcome
- Sponsor
- PT Bio Farma
Vaccine Reaction, Vaccine Adverse Reaction
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses…
- Trial name
- NCT05482295
- Testing
- In-House Recombinant Hepatitis B (Bio Farma) vaccine, Registered Hepatitis B vaccine recombinant (Engerix-B)
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma