Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
1 other identifier
interventional
540
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJune 6, 2025
June 1, 2025
8 months
July 29, 2022
June 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Protectivity
Number \& percentage of subjects with anti HBsAg \> 10mIU/ml
28 days after the primary series of Hepatitis B vaccination
Secondary Outcomes (7)
Immunogenicity: Serological response
28 days after the primary series of Hepatitis B vaccination
Immunogenicity: comparison between IP & control
28 days after the primary series of Hepatitis B vaccination
Immunogenicity: comparison among each batch of IP
28 days after the primary series of Hepatitis B vaccination
Safety: Immediate reaction, Local and systemic events
within the first 30 minutes, after 30 minutes to 7 days, after 7 days to 28 days after each injection
Safety: Serious adverse event
from inclusion until 28 days after the last injection
- +2 more secondary outcomes
Study Arms (4)
In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 1
EXPERIMENTAL3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine
In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 2
EXPERIMENTAL3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine
In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 3
EXPERIMENTAL3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine
Registered Hepatitis B vaccine recombinant (Engerix-B)
ACTIVE COMPARATOR3 doses Registered Hepatitis B vaccine recombinant (Engerix-B)
Interventions
3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PT Bio Farmalead
- RS Prof. Dr. I.G.N.G Ngoerahcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Trisna Windiani, MD
RSUP Prof. dr. I.G.N.G. Ngoerah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The subject will be randomized and vaccinated per treatment group by unblinded team. The randomization list will be provided by unblinded personel of study team. This unblinded team will keep the list until Bio Farma formally issue the result of the study. Treatment will be allocated in accordance with a randomization list, so that to each randomization number, corresponds only one strictly randomly assigned treatment group (A/B/C/D).
- 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
September 1, 2025
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
June 6, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share