Study Stopped
The products will be replace with others.
Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)
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
1 other identifier
interventional
N/A
1 country
3
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2025
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 1, 2022
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
June 5, 2025
June 1, 2025
1 year
July 29, 2022
June 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
28 days
Secondary Outcomes (4)
To asses the local and systemic reactions within 30 minutes
30 minutes
To asses the local and systemic reactions within 30 minutes to 7 days after immunization
7 days
To asses the local and systemic reactions within 7 days to 28 days after immunization
28 days
To asses the serious adverse event
28 days
Study Arms (2)
Recombinant Hep B new Bulk + Penta with Recombinant HepB new Bulk
EXPERIMENTAL1 dose Recombinant Hepatitis B new Bulk vaccine at birth + 3 doses Pentavalent with Recombinant HepB new Bulk vaccine
Hep B (Registered) + Pentabio (Registered)
ACTIVE COMPARATOR1 dose Recombinant Hepatitis B vaccine (Registered) + 3 doses Pentabio with Recombinant HepB new Bulk vaccine
Interventions
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.
3 doses of DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
1 dose of Recombinant Hepatitis B vaccine (Registered Bio Farma)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)).
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PT Bio Farmalead
- Hasan Sadikin General Hospitalcollaborator
Study Sites (3)
Garuda Primary Health Centre
Bandung, West Java, Indonesia
Ibrahim Adjie Primary Health Centre
Bandung, West Java, Indonesia
Puter Primary Health Centre
Bandung, West Java, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eddy Fadlyana, MD
Hasan Sadikin General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double (Participant, Investigator) Observer Blind : Investigational Product and Active Comparator are masking Lot number is masking
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2022
First Posted
August 1, 2022
Study Start
December 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
June 5, 2025
Record last verified: 2025-06