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

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. A total of 540 subjects will be involved in this 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.

Conditions

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Vaccine Reaction Vaccine Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental, randomized, observer-blind, lot to lot consistency

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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).

Study Groups

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In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 1

3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine

Group Type EXPERIMENTAL

In-House Recombinant Hepatitis B (Bio Farma) vaccine

Intervention Type BIOLOGICAL

3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine

In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 2

3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine

Group Type EXPERIMENTAL

In-House Recombinant Hepatitis B (Bio Farma) vaccine

Intervention Type BIOLOGICAL

3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine

In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 3

3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine

Group Type EXPERIMENTAL

In-House Recombinant Hepatitis B (Bio Farma) vaccine

Intervention Type BIOLOGICAL

3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine

Registered Hepatitis B vaccine recombinant (Engerix-B)

3 doses Registered Hepatitis B vaccine recombinant (Engerix-B)

Group Type ACTIVE_COMPARATOR

Registered Hepatitis B vaccine recombinant (Engerix-B)

Intervention Type BIOLOGICAL

3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)

Interventions

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In-House Recombinant Hepatitis B (Bio Farma) vaccine

3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine

Intervention Type BIOLOGICAL

Registered Hepatitis B vaccine recombinant (Engerix-B)

3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. 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.
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 \>= 37.5 C) 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 immunosuppressant.
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

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes