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

Launched by PT BIO FARMA · Jul 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new Hepatitis B vaccine made in-house to see how effective it is at protecting people from the virus after getting three doses. The main goal is to see how well the vaccine works 28 days after the last dose. This study is not yet recruiting participants, but it will involve healthy individuals aged between 10 and 35 years from Indonesia.

To be eligible for the trial, participants must be in good health and not have any serious medical conditions. They should also not have received any Hepatitis B vaccinations in the past 10 years and must not have any known allergies to vaccine components. Participants will need to agree to follow the study's instructions and provide informed consent. Throughout the trial, participants will receive the vaccine and be monitored for any reactions or side effects to ensure safety.

Gender

ALL

Eligibility criteria

• 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.