NCT05482295Not yet recruitingPhase 3
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Registered Hepatitis B Vaccine in Indonesian Population (Phase III)
Source: ClinicalTrials.gov · Last updated 6 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 immunization.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 540 (estimated)
- First submitted
- 29 Jul 2022
- Start date
- Sept 2025
- Primary completion date
- May 2026
- Lead sponsor
- PT Bio Farma
- Diseases
- Hepatitis B
- NCT number
- NCT05482295
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 540
- From Sept 2025 to the primary completion date, May 2026
- 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
- Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppressant.
- Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
Other illness
- Subjects with known history of Hepatitis B contained vaccination in the last 10 years.
- Evolving severe illness and/or chronic disease and fever (axillary temperature \>= 37.5 C) within the 48 hours preceding enrollment.
- Known history of allergy to any component of the vaccines (based on anamnesis).
- Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
Other
- Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- HBsAg positive.
- Pregnancy \& Lactation (Adult).
Who the study is looking for
- Healthy individual aged 10 - 50 years old, as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator.
- Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form.
- Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.
Age in the registry: 10 years to 50 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.