Vaccine ReactionPhase 3NCT05482295
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
A Phase 3 study testing In-House Recombinant Hepatitis B (Bio Farma) vaccine and Registered Hepatitis B vaccine recombinant (Engerix-B) in people with Vaccine Reaction and Vaccine Adverse Reaction, run by PT Bio Farma.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction, Vaccine Adverse Reaction
- What is being tested?
- In-House Recombinant Hepatitis B (Bio Farma) vaccine and Registered Hepatitis B vaccine recombinant (Engerix-B)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- Pregnancy \& Lactation (Adult).
- Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Registered Hepatitis B Vaccine in Indonesian Population (Phase III)
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.
Read the detailed description
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.
- Conditions
- Vaccine Reaction, Vaccine Adverse Reaction
- Being tested
- In-House Recombinant Hepatitis B (Bio Farma) vaccine, Registered Hepatitis B vaccine recombinant (Engerix-B)
- Keywords
- Hepatitis B vaccine, Vaccine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-House Recombinant Hepatitis B (Bio Farma) vaccineBiological
3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
Registered Hepatitis B vaccine recombinant (Engerix-B)Biological
3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)
| Study group | Role | What they receive |
|---|---|---|
| In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 1 | Experimental | 3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine Receives: Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine |
| In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 2 | Experimental | 3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine Receives: Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine |
| In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 3 | Experimental | 3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine Receives: Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine |
| Registered Hepatitis B vaccine recombinant (Engerix-B) | Active comparator | 3 doses Registered Hepatitis B vaccine recombinant (Engerix-B) Receives: Biological: Registered Hepatitis B vaccine recombinant (Engerix-B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protectivity
Number \& percentage of subjects with anti HBsAg > 10mIU/ml
Measured: 28 days after the primary series of Hepatitis B vaccination
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 28 days after the primary series of Hepatitis B vaccination
Safety: Immediate reaction, Local and systemic events
Immediate reaction, Local and systemic events
Measured: 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
Measured: 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
Measured: 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
Measured: 28 days after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study startSep 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, randomized, observer-blind, lot to lot consistency
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RSUP Prof. Dr. I.G.N.G. Ngoerahal
- Responsible party
- Sponsor
- Investigators
- Trisna Windiani, MD, Principal investigator, RSUP Prof. dr. I.G.N.G. Ngoerah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482295
- Sponsor's protocol ID
- HepB 0322
- Status last verified
- Jun 2025
- First submitted
- 29 Jul 2022
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Registered Hepatitis B Vaccine in Indonesian Population (Phase III)
- ClinicalTrials.gov ID
- NCT05482295
- Acronym / sponsor ID
- HepB 0322
- Conditions
- Vaccine Reaction, Vaccine Adverse Reaction
- Keywords
- Hepatitis B vaccine, Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- RSUP Prof. Dr. I.G.N.G. Ngoerahal
- Study start
- Sep 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Experimental, randomized, observer-blind, lot to lot consistency
| Arm | Type | Receives |
|---|---|---|
| In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 1 | Experimental | Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine |
| In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 2 | Experimental | Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine |
| In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 3 | Experimental | Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine |
| Registered Hepatitis B vaccine recombinant (Engerix-B) | Active comparator | Biological: Registered Hepatitis B vaccine recombinant (Engerix-B)3 doses Registered Hepatitis B vaccine recombinant (Engerix-B) |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-House Recombinant Hepatitis B (Bio Farma) vaccine3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine | Biological | In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 1, In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 2, In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 3 |
| Registered Hepatitis B vaccine recombinant (Engerix-B)3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B) | Biological | Registered Hepatitis B vaccine recombinant (Engerix-B) |
Primary outcome
Protectivity
Time frame: 28 days after the primary series of Hepatitis B vaccination
Number \& percentage of subjects with anti HBsAg > 10mIU/ml
7 secondary outcomes
Immunogenicity: Serological response
Time frame: 28 days after the primary series of Hepatitis B vaccination
Immunogenicity: comparison between IP & control
Time frame: 28 days after the primary series of Hepatitis B vaccination
Immunogenicity: comparison among each batch of IP
Time frame: 28 days after the primary series of Hepatitis B vaccination
Safety: 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
Time frame: from inclusion until 28 days after the last injection
Safety: Comparison of adverse events between Investigational Products (Hepatitis B) and Control
Time frame: 28 days after each dose
Safety: Comparison of adverse events between each lot number of Recombinant Hepatitis B
Time frame: 28 days after each dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trisna Windiani, MD principal investigator
RSUP Prof. dr. I.G.N.G. Ngoerah
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing In-House Recombinant Hepatitis B (Bio Farma) vaccine and Registered Hepatitis B vaccine recombinant (Engerix-B) in people with Vaccine Reaction and Vaccine Adverse Reaction, run by PT Bio Farma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rini Mulia Sari, MD (0222033755 ext. 14102, rini.mulia@biofarma.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protectivity (time frame: 28 days after the primary series of Hepatitis B vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.