clinical trial · NCT07854847
Study Interchangeability Hep-B Vaccine Administered at Birth Dose
PT Bio Farma·phase3·not yet recruiting·n = 270
Vaccination Adverse EventImmunogenicity, VaccineIn-house Hepatitis B VaccineRegistered Hepatitis B Vaccine
brief summary
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
started
Oct 1, 2026
primary completion
Feb 1, 2027
completion
Jul 1, 2027
last updated
Oct 2, 2026
detailed description
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
Approximately 270 newborns will be enrolled in this trial, divided into 2 arms, with the ratio 1:1. The subject will receive one dose of In-House Recombinant Hepatitis B at birth or registered monovalent Hepatitis B as a control then followed by registered DTwP-HepB-IPVHib (HEXASIIL) vaccine
official title
Randomized, Double-Blind, Interchangeability Study of In-House Recombinant Hepatitis B (Bio Farma) at Birth Dose Followed by RRegistered DTwP-HepB-IPV-Hib (HEXASIIL) Vaccine in Indonesian Infants
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol