NCT07854847Not yet recruitingPhase 3
Study Interchangeability Hep-B Vaccine Administered at Birth Dose
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 28 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- PT Bio Farma
- Diseases
- Hepatitis B
- NCT number
- NCT07854847
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 270
- From 1 Oct 2026 to the primary completion date, 28 Feb 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Infants received or plans to receive any treatment likely to alter the immune response intravenously (immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)).
- Infants received other vaccinations with the exception of BCG, poliomyelitis, rotavirus, and PCV.
Other illness
- Infants evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C on Day 0).
- Infants suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis.
- Infants with HbsAg and HIV positive (from cord blood)
- Mother suspected of immunodeficiency disease based on anamnesis
Other
- Infants concomitantly enrolled or scheduled to be enrolled in another trial.
Who the study is looking for
- Healthy, full term, newborn infants.
- Infant born between 37-42 weeks of pregnancy.
- Infant weigh between 2500 - 4000 gram at birth.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.
Age in the registry: 0 days to 3 days · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.