Protectivity and Safety Following Recombinant Hepatitis B Vaccine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

536 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-11

Study Completion Date

2020-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children

NCT04188223

Hepatitis B

COMPLETED PHASE1

Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

NCT00356564

Hepatitis B

COMPLETED PHASE4

Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)

NCT05482295

Vaccine Reaction Vaccine Adverse Reaction

NOT_YET_RECRUITING PHASE3

Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine

NCT02152709

Hepatitis B

COMPLETED PHASE3

Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

NCT00335881

Hepatitis B

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population.

Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immunogenicity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental, randomized, double blind, four arm parallel group study

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Investigational product was masking with control

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hep B Batch 1

1 dose of 1 mL Hepatitis B Batch 1

Group Type EXPERIMENTAL

Recombinant Hepatitis B vaccine

Intervention Type BIOLOGICAL

Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.

Hep B Batch 2

1 dose of 1 mL Hepatitis B Batch 2

Group Type EXPERIMENTAL

Recombinant Hepatitis B vaccine

Intervention Type BIOLOGICAL

Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.

Hep B Batch 3

1 dose of 1 mL Hepatitis B Batch 3

Group Type EXPERIMENTAL

Recombinant Hepatitis B vaccine

Intervention Type BIOLOGICAL

Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.

Hep B (Bio Farma)

1 dose of 1 mL Hepatitis B (Bio Farma)

Group Type ACTIVE_COMPARATOR

Recombinant Hepatitis B (Bio Farma)

Intervention Type BIOLOGICAL

Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from The Janssen Vaccine Corp and then formulated and filled at Bio Farma.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Recombinant Hepatitis B vaccine

Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.

Intervention Type BIOLOGICAL

Recombinant Hepatitis B (Bio Farma)

Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from The Janssen Vaccine Corp and then formulated and filled at Bio Farma.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Healthy individu 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.
2. Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form.
3. Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
2. Subjects with known history of Hepatitis B contained vaccination in the last 10 years
3. Evolving severe illness and/or chronic disease and fever (axillary temperature more than37.5oC) within the 48 hours preceding enrollment.
4. Known history of allergy to any component of the vaccines (based on anamnesis)
5. HBsAg positive
6. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
7. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
8. 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 immunosuppresant.
9. Pregnancy \& Lactation (Adult)
10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.

Minimum Eligible Age

10 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes