Protectivity and Safety Following Recombinant Hepatitis B Vaccine

PT Bio Farma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Immunogenicity

Treatments: Biological: Recombinant Hepatitis B (Bio Farma); Biological: Recombinant Hepatitis B vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03919578

Hep B 0218

Details and patient eligibility

About

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

Full description

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.

Enrollment: 536 patients

Sex: All

Ages: 10 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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536 participants in 4 patient groups

Hep B Batch 1

Experimental group

Description:

1 dose of 1 mL Hepatitis B Batch 1

Treatment:

Biological: Recombinant Hepatitis B vaccine

Hep B Batch 2

Experimental group

Description:

1 dose of 1 mL Hepatitis B Batch 2

Treatment:

Biological: Recombinant Hepatitis B vaccine

Hep B Batch 3

Experimental group

Description:

1 dose of 1 mL Hepatitis B Batch 3

Treatment:

Biological: Recombinant Hepatitis B vaccine

Hep B (Bio Farma)

Active Comparator group

Description:

1 dose of 1 mL Hepatitis B (Bio Farma)

Treatment:

Biological: Recombinant Hepatitis B (Bio Farma)