Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Popula… (NCT05482295) | Clinical Trial Compass
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 range
10 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Protectivity
Timeframe: 28 days after the primary series of Hepatitis B vaccination
. 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.