Not Yet RecruitingPhase 3

Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)

540 participantsStarted 2025-09

Plain-language summary

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.

Who can participate

Age range10 Years – 50 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
✕. 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).
✕. HBsAg positive.
✕. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
✕. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
✕. 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.

What they're measuring

Protectivity

Timeframe: 28 days after the primary series of Hepatitis B vaccination

Trial details

NCT IDNCT05482295

SponsorPT Bio Farma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Rini Mulia Sari, MD

0222033755 rini.mulia@biofarma.co.id

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