A Phase 3 interventional study of In-House Recombinant Hepatitis B (Bio Farma) vaccine and Registered Hepatitis B vaccine recombinant (Engerix-B) in Vaccine Reaction and Vaccine Adverse Reaction, sponsored by PT Bio Farma. Not yet recruiting. Open to participants aged 10 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by PT Bio Farma · Phase 3, Interventional, and Prevention
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.
This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. A total of 540 subjects will be involved in this 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.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 540 is above the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →PT Bio Farma is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine
Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine
3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine
Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine
3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine
Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine
3 doses Registered Hepatitis B vaccine recombinant (Engerix-B)
Biological: Registered Hepatitis B vaccine recombinant (Engerix-B)
3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)
Protectivity
Number \& percentage of subjects with anti HBsAg \> 10mIU/ml
Time frame: 28 days after the primary series of Hepatitis B vaccination
Immunogenicity: Serological response
Geometric mean of anti-HBsAg, percentage of subjects with increasing antibody titer \>= 4 times and/ or percentage of subjects with transition of seronegative to seropositive
Time frame: 28 days after the primary series of Hepatitis B vaccination
Immunogenicity: comparison between IP & control
Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \>=4 times and/ or percentage of subjects with transition of seronegative to seropositive
Time frame: 28 days after the primary series of Hepatitis B vaccination
Immunogenicity: comparison among each batch of IP
Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \>=4 times and/ or percentage of subjects with transition of seronegative to seropositive
Time frame: 28 days after the primary series of Hepatitis B vaccination
Safety: Immediate reaction, Local and systemic events
Immediate reaction, Local and systemic events
Time frame: within the first 30 minutes, after 30 minutes to 7 days, after 7 days to 28 days after each injection
Safety: Serious adverse event
Any serious adverse event
Time frame: from inclusion until 28 days after the last injection
Safety: Comparison of adverse events between Investigational Products (Hepatitis B) and Control
Adverse events occuring until 28 days after vaccination
Time frame: 28 days after each dose
Safety: Comparison of adverse events between each lot number of Recombinant Hepatitis B
Adverse events occuring until 28 days after vaccination
Time frame: 28 days after each dose
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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