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

Study Overview
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Brief Summary
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This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency.

Detailed Description
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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.

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

Conditions
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Vaccine Reaction, Vaccine Adverse Reaction

Intervention / Treatment
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* Biological: Hepatitis B vaccine lot 1
* Biological: Hepatitis B vaccine lot 2
* Biological: Hepatitis B vaccine lot 3
* Biological: Hepatitis B vaccine (registered)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepatitis B vaccine lot 1<br>3 doses Recombinant Hepatitis B new Bulk vaccine lot 1 | Biological: Hepatitis B vaccine lot 1<br>* 3 doses of Hepatitis B vaccine lot 1<br>|
| Experimental: Hepatitis B vaccine lot 2<br>3 doses Recombinant Hepatitis B new Bulk vaccine lot 2 | Biological: Hepatitis B vaccine lot 2<br>* 3 doses of Hepatitis B vaccine lot 2<br>|
| Experimental: Hepatitis B vaccine lot 3<br>3 doses Recombinant Hepatitis B new Bulk vaccine lot 3 | Biological: Hepatitis B vaccine lot 3<br>* 3 doses of Hepatitis B vaccine lot 3<br>|
| Active Comparator: Active Control: Hepatitis B vaccine (registered)<br>3 doses Recombinant Hepatitis B vaccine (registered) | Biological: Hepatitis B vaccine (registered)<br>* 3 doses of Hepatitis B vaccine (registered)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with increasing antibody titer >= 4 times | Percentage of subjects with increasing antibody titer >= 4 times: in all subjects; | 28 days after the last dose immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) | GMT in all subjects; comparison of GMT between investigational products and control and comparison of GMT between each lot number of Recombinant Hepatitis B | 28 days after the last dose immunization | 
| Percentage of subjects with transition of seronegative to seropositive | Percentage of subjects with transition of seronegative to seropositive: in all subjects; | 28 days after the last dose immunization | 
| Percentage of subjects with at least one immediate reaction | Immediate reaction (local reaction or systemic event) | 30 minutes after each vaccination | 
| Percentage of subjects with at least one of these adverse events | At least one of these adverse events, expected or not | within 72 hours, between 72 hours to 28 days after vaccination | 
| Serious adverse event after vaccination | Serious adverse event occurring from inclusion until 28 days after vaccination. | 28 days after the last dose immunization | 
| Comparison adverse events between Investigational Products (Hepatitis B) and Control | Adverse events occuring until 28 days after vaccination | 28 days after each dose | 
| Comparison of adverse events between each lot number of Recombinant Hepatitis B | Adverse events occuring until 28 days after vaccination | 28 days after each dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B vaccine, Vaccine