Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Hepatitis B (Bio Farma)® Vaccine in Indonesian Population

Hep B 0322

This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.

2024-06-01

2024-07-01

2024-08-01

Not yet recruiting

Early phase I

540

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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 immunosuppresant. * Pregnancy \& Lactation (Adult). * Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 540, 'type': 'ESTIMATED'}}

2024-04-05