NCT05482282 - Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) | Biotech Hunter

Timeline

Start Date

December 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions

Diphtheria Vaccine Adverse ReactionTetanus Vaccine Adverse ReactionPertussis Vaccine Adverse ReactionHaemophilus Influenzae Type B Vaccine Adverse ReactionHepatitis B Vaccine Adverse Reaction

Interventions

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

Trial Locations (3)

Unknown

Garuda Primary Health Centre, Bandung

Ibrahim Adjie Primary Health Centre, Bandung

Puter Primary Health Centre, Bandung