Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
Study Details
Study Description
Brief Summary
This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency. The objective of the study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization, to assess the safety of In-House Recombinant Hepatitis B vaccine, to evaluate immunogenicity and safety in three consecutive batches of In-House Recombinant Hepatitis B vaccine and also evaluate immunogenicity and safety after primary series of investigational product compare to control.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hepatitis B vaccine lot 1 3 doses Recombinant Hepatitis B new Bulk vaccine lot 1 |
Biological: Hepatitis B vaccine lot 1
3 doses of Hepatitis B vaccine lot 1
|
| Experimental: Hepatitis B vaccine lot 2 3 doses Recombinant Hepatitis B new Bulk vaccine lot 2 |
Biological: Hepatitis B vaccine lot 2
3 doses of Hepatitis B vaccine lot 2
|
| Experimental: Hepatitis B vaccine lot 3 3 doses Recombinant Hepatitis B new Bulk vaccine lot 3 |
Biological: Hepatitis B vaccine lot 3
3 doses of Hepatitis B vaccine lot 3
|
| Active Comparator: Active Control: Hepatitis B vaccine (registered) 3 doses Recombinant Hepatitis B vaccine (registered) |
Biological: Hepatitis B vaccine (registered)
3 doses of Hepatitis B vaccine (registered)
|
Outcome Measures
Primary Outcome Measures
- Percentage of subjects with increasing antibody titer >= 4 times [28 days after the last dose immunization]
Percentage of subjects with increasing antibody titer >= 4 times: in all subjects;
Secondary Outcome Measures
- Geometric Mean Titer (GMT) [28 days after the last dose immunization]
GMT in all subjects; comparison of GMT between investigational products and control and comparison of GMT between each lot number of Recombinant Hepatitis B
- Percentage of subjects with transition of seronegative to seropositive [28 days after the last dose immunization]
Percentage of subjects with transition of seronegative to seropositive: in all subjects;
- Percentage of subjects with at least one immediate reaction [30 minutes after each vaccination]
Immediate reaction (local reaction or systemic event)
- Percentage of subjects with at least one of these adverse events [within 72 hours, between 72 hours to 28 days after vaccination]
At least one of these adverse events, expected or not
- Serious adverse event after vaccination [28 days after the last dose immunization]
Serious adverse event occurring from inclusion until 28 days after vaccination.
- Comparison adverse events between Investigational Products (Hepatitis B) and Control [28 days after each dose]
Adverse events occuring until 28 days after vaccination
- Comparison of adverse events between each lot number of Recombinant Hepatitis B [28 days after each dose]
Adverse events occuring until 28 days after vaccination
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/informed assent form.
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Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion Criteria:
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Subject concomitantly enrolled or scheduled to be enrolled in another trial.
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Subjects with known history of Hepatitis B contained vaccination in the last 10 years.
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Evolving severe illness and/or chronic disease and fever (axillary temperature ≥ 37.5°C) within the 48 hours preceding enrollment.
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Known history of allergy to any component of the vaccines (based on anamnesis).
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HBsAg positive.
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Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
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History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
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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.
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Pregnancy & Lactation (Adult).
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Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- PT Bio Farma
- RS Umum Pusat Sanglah, Denpasar
Investigators
- Principal Investigator: Trisna Windiani, MD, RS Umum Pusat Sanglah
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Hep B 0322