Diphtheria Vaccine Adverse ReactionPhase 3NCT05482282
Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)
A Phase 3 study testing Recombinant Hepatitis B new Bulk vaccine, DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine and Recombinant Hepatitis B vaccine (Registered BioFarma) in people with Diphtheria Vaccine Adverse Reaction and Tetanus Vaccine Adverse Reaction, run by PT Bio Farma at 3 sites in Indonesia.
Trial summary
This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma). Read more about this study
- Who is it for?
- Ages 1 day to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse Reaction
- What is being tested?
- Recombinant Hepatitis B new Bulk vaccine, DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine and Recombinant Hepatitis B vaccine (Registered BioFarma)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesIndonesia
- Study dates
- Dec 2025to Dec 2026
- Phase
- Phase 3
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 1 day to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, full term, newborns infants.
- Infant born after 37-42 weeks of pregnancy.
- Infant weighing 2500 gram or more 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
- Child concomitantly enrolled or scheduled to be enrolled in another trial.
- Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0).
- Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis.
- Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis
- Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis
- Child received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
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- Child received other vaccination with the exception of BCG and poliomyelitis.
- Child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- Mother with HbsAg and HIV positive (by rapid test within 30 days prior subject's birth)
- Mother suspected of immunodeficiency disease based on anamnesis
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Garuda Primary Health Centre
Bandung, West Java
Ibrahim Adjie Primary Health Centre
Bandung, West Java
Puter Primary Health Centre
Bandung, West Java
About this study
Official title: Comparison of Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose Using New Hepatitis B Bulk (Bio Farma), in Indonesian Infants
This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).
Read the detailed description
This bridging study is a randomized, double blind, two arms parallel groups, prospective intervention study. Total 220 infants, 0-3 days old will be involved in this study. The subject will be divided into 2 groups, 110 subjects are the investigational group and 110 subjects are the active comparator group.
The objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma) and to asses the safety of DTP-HB-Hib Vaccine (Bio Farma) and Recombinant Hepatitis B Vaccine using new Hepatitis B bulk (Bio Farma).
- Conditions
- Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse Reaction, Haemophilus Influenzae Type B Vaccine Adverse Reaction, Hepatitis B Vaccine Adverse Reaction
- Being tested
- Recombinant Hepatitis B new Bulk vaccine, DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine, Recombinant Hepatitis B vaccine (Registered BioFarma), Pentabio
- Keywords
- DTP-HB-Hib Vaccine, Hepatitis B 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.
Recombinant Hepatitis B new Bulk vaccineBiological
1 dose of Recombinant Hepatitis B vaccine using new Hepatitis B bulk (Bio Farma)
1 dose of 0.5 ml Recombinant Hepatitis B new Bulk vaccine dose of DTP-HB-Hib using new Hepatitis B Bulk vaccine injected intramuscularly into the left external antero-lateral thigh region.
DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccineBiological
3 doses of DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
Recombinant Hepatitis B vaccine (Registered BioFarma)Biological
1 dose of Recombinant Hepatitis B vaccine (Registered Bio Farma)
PentabioBiological
3 doses of Pentabio
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Hep B new Bulk + Penta with Recombinant HepB new Bulk | Experimental | 1 dose Recombinant Hepatitis B new Bulk vaccine at birth + 3 doses Pentavalent with Recombinant HepB new Bulk vaccine Receives: Biological: Recombinant Hepatitis B new Bulk vaccine; Biological: DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine |
| Hep B (Registered) + Pentabio (Registered) | Active comparator | 1 dose Recombinant Hepatitis B vaccine (Registered) + 3 doses Pentabio with Recombinant HepB new Bulk vaccine Receives: Biological: Recombinant Hepatitis B vaccine (Registered BioFarma); Biological: Pentabio |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma)
Percentage of infants with anti-diphtheria titer and anti-tetanus titer more than 0.01 IU/ml, anti HbsAg titer more than 10 mIU/ml, and anti PRP-TT titer more than 0.15 microgram/ml 28 days after the last injection of DTP-HB-Hib using new Hepatitis B bulk (Bio Farma) vaccine group.
Measured: 28 days
Secondary outcomes (4)
To asses the local and systemic reactions within 30 minutes
Local reaction and systemic events occurring within 30 minutes after immunization.
Measured: 30 minutes
To asses the local and systemic reactions within 30 minutes to 7 days after immunization
Local reaction and systemic events occurring after 30 minutes to 7 days after immunization.
Measured: 7 days
To asses the local and systemic reactions within 7 days to 28 days after immunization
Local reaction and systemic events occurring after 7 days to 28 days following the vaccination.
Measured: 28 days
To asses the serious adverse event
Any serious adverse event occuring from inclusion until 28 days after the last dose
Measured: 28 days
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 startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: The products will be replace with others.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diphtheria Vaccine Adverse 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
- Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hasan Sadikin General Hospital
- Responsible party
- Sponsor
- Investigators
- Eddy Fadlyana, MD, Principal investigator, Hasan Sadikin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482282
- Sponsor's protocol ID
- Penta BS22
- Status last verified
- Jun 2025
- First submitted
- 29 Jul 2022
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No