Vaccination Adverse EventPhase 3NCT07854847
Study Interchangeability Hep-B Vaccine Administered at Birth Dose
A Phase 3 study testing In-house Hepatitis B Vaccine and Registered Hepatitis B Vaccine in people with Vaccination Adverse Event and Immunogenicity, Vaccine, run by PT Bio Farma.
Trial summary
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study. Read more about this study
- Who is it for?
- Ages 0 to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Vaccination Adverse Event, Immunogenicity, Vaccine
- What is being tested?
- In-house Hepatitis B Vaccine and Registered Hepatitis B Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jul 2027
- 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 0 to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, full term, newborn infants.
- Infant born between 37-42 weeks of pregnancy.
- Infant weigh between 2500 - 4000 gram at birth.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.
Who cannot join
- Infants concomitantly enrolled or scheduled to be enrolled in another trial.
- Infants evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C on Day 0).
- Infants suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis.
- Infants received or plans to receive any treatment likely to alter the immune response intravenously (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
- Infants received other vaccinations with the exception of BCG, poliomyelitis, rotavirus, and PCV.
- Infants with HbsAg and HIV positive (from cord blood)
- Mother suspected of immunodeficiency disease based on anamnesis
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: Randomized, Double-Blind, Interchangeability Study of In-House Recombinant Hepatitis B (Bio Farma) at Birth Dose Followed by RRegistered DTwP-HepB-IPV-Hib (HEXASIIL) Vaccine in Indonesian Infants
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
Read the detailed description
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
Approximately 270 newborns will be enrolled in this trial, divided into 2 arms, with the ratio 1:1. The subject will receive one dose of In-House Recombinant Hepatitis B at birth or registered monovalent Hepatitis B as a control then followed by registered DTwP-HepB-IPVHib (HEXASIIL) vaccine
- Conditions
- Vaccination Adverse Event, Immunogenicity, Vaccine
- Being tested
- In-house Hepatitis B Vaccine, Registered Hepatitis B Vaccine
- Keywords
- Vaccine, Hepatitis B
- 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 Hepatitis B VaccineBiological
0,5 ml In-House Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh
Registered Hepatitis B VaccineBiological
0,5 ml Registered Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh
| Study group | Role | What they receive |
|---|---|---|
| Hep B vaccine in-house | Experimental | 0,5 ml of In-house Recombinant Hepatitis B (Bio Farma) vaccine injected at birth Receives: Biological: In-house Hepatitis B Vaccine |
| Registered Hep B vaccine | Active comparator | 0,5 ml of Regstered Hepatitis B (Bio Farma) vaccine injected at birth Receives: Biological: Registered Hepatitis B Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protectivity of primary series In-House Recombinant Hepatitis B vaccine
Percentage of subjects with anti HBsAg > 10mIU/ml after the completion of the primary series of recombinant hepatitis B and Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine for each group
Measured: 28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
Secondary outcomes (4)
Immunogenicity of birth dose In-House Recombinant Hepatitis B vaccine
GMT and percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive after birth dose Hep B vaccine
Measured: 28 days after administration of Hep B birth dose vaccine
Immunogenicity of In-House recombinant Hepatitis B vaccine after the completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
GMT and percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive after completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
Measured: 28 days after the third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
Safety of In-House Recombinant Hepatitis B vaccine
Percentage of subjects with solicited and unsolicited adverse events after each dose
Measured: 30 minutes, 7 days, 28 days after each dose
Serious Adverse Events
Percentage of infants with at least one serious adverse events
Measured: 28 days after third dose of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination Adverse EventStudies 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
- Randomized, double-blind, two arms parallel groups, prospective intervention study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitas Padjadjaran
- Responsible party
- Sponsor
- Investigators
- Rodman Tarigan Girsang, MD, Principal investigator, Faculty of Medicine, Padjadjaran University, Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854847
- Sponsor's protocol ID
- HepB0226
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Interchangeability Study of In-House Recombinant Hepatitis B (Bio Farma) at Birth Dose Followed by RRegistered DTwP-HepB-IPV-Hib (HEXASIIL) Vaccine in Indonesian Infants
- ClinicalTrials.gov ID
- NCT07854847
- Acronym / sponsor ID
- HepB0226
- Conditions
- Vaccination Adverse Event, Immunogenicity, Vaccine
- Keywords
- Vaccine, Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Universitas Padjadjaran
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Oct 2026 (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 trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
Detailed description
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
Approximately 270 newborns will be enrolled in this trial, divided into 2 arms, with the ratio 1:1. The subject will receive one dose of In-House Recombinant Hepatitis B at birth or registered monovalent Hepatitis B as a control then followed by registered DTwP-HepB-IPVHib (HEXASIIL) vaccine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, two arms parallel groups, prospective intervention study.
| Arm | Type | Receives |
|---|---|---|
| Hep B vaccine in-house | Experimental | Biological: In-house Hepatitis B Vaccine0,5 ml of In-house Recombinant Hepatitis B (Bio Farma) vaccine injected at birth |
| Registered Hep B vaccine | Active comparator | Biological: Registered Hepatitis B Vaccine0,5 ml of Regstered Hepatitis B (Bio Farma) vaccine injected at birth |
Who may qualify
- Ages
- 0 to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy, full term, newborn infants.
- Infant born between 37-42 weeks of pregnancy.
- Infant weigh between 2500 - 4000 gram at birth.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.
Key exclusion criteria (7 listed)
- Infants concomitantly enrolled or scheduled to be enrolled in another trial.
- Infants evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C on Day 0).
- Infants suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis.
- Infants received or plans to receive any treatment likely to alter the immune response intravenously (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
- Infants received other vaccinations with the exception of BCG, poliomyelitis, rotavirus, and PCV.
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 Hepatitis B Vaccine0,5 ml In-House Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh | Biological | Hep B vaccine in-house |
| Registered Hepatitis B Vaccine0,5 ml Registered Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh | Biological | Registered Hep B vaccine |
Primary outcome
Protectivity of primary series In-House Recombinant Hepatitis B vaccine
Time frame: 28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
Percentage of subjects with anti HBsAg > 10mIU/ml after the completion of the primary series of recombinant hepatitis B and Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine for each group
4 secondary outcomes
Immunogenicity of birth dose In-House Recombinant Hepatitis B vaccine
Time frame: 28 days after administration of Hep B birth dose vaccine
Immunogenicity of In-House recombinant Hepatitis B vaccine after the completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
Time frame: 28 days after the third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
Safety of In-House Recombinant Hepatitis B vaccine
Time frame: 30 minutes, 7 days, 28 days after each dose
Serious Adverse Events
Time frame: 28 days after third dose of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine administration
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 2 Oct 2026.
- 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.
Rodman Tarigan Girsang, MD principal investigator
Faculty of Medicine, Padjadjaran University, Bandung
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing In-house Hepatitis B Vaccine and Registered Hepatitis B Vaccine in people with Vaccination Adverse Event and Immunogenicity, Vaccine, 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 5 inclusion and 7 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 2 Oct 2026. 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 (+622033755 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 of primary series In-House Recombinant Hepatitis B vaccine (time frame: 28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine). 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 2 Oct 2026.