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This trial is an experimental, randomized, double blind, prospective intervention study
Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow:
For adult (18-40 years old)
Each study age group/arm will be divided into two groups of treatment. One group will receive investigational product and one other group will receive active comparator. This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) ). Before the study started, the subjects will be assessed for anti HBs Antibody. For subjects with anti-HBs not protective (< 10mIU/mL) before immunization, additional 2 doses will be required with 1 month interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Hepatitis B (Bio Farma) Vaccine | Experimental | Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg and purified and inactivated by several physicochemical steps such as ultracentrifugation, column chromatography and formaldehyde treatment. |
|
| Control Product: Recombinant Hepatitis B (Bio Farma) Vaccine® | Active Comparator | Registered Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg and purified and inactivated by several physicochemical steps such as ultracentrifugation, column chromatography and formaldehyde treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Hepatitis B (Bio Farma) Vaccine | Biological | Recombinant Hepatitis B vaccine produced by Bio Farma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Immediate reaction | Number of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination | 3 months |
| percentage of subjects with Immediate reaction | Percentage of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Adverse Events from 1 day to 28 days after vaccination | Number of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each dose vaccination | 3 months |
| Percentage of subjects with Adverse Events from 1 day to 28 days after vaccination |
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Inclusion Criteria:
Adult
Children:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kusnandi Rusmil, Professor | Padjadjaran University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasan Sadikin Hospital | Bandung | West Java | 40161 | Indonesia |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D007239 | Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) )
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Double blind.
| Recombinant Hepatitis B (Bio Farma) Vaccine® | Biological | Registered Recombinant Hepatitis B vaccine produced by Bio Farma |
|
Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each dose vaccination |
| 3 months |
| Number of subjects with Serious Adverse Events from 1 day to 28 days after vaccination | Number of subjects with serious adverse event from inclusion until 28 day after each dose vaccination. | 3 Months |
| Percentage of subjects with serious Adverse Events from 1 day to 28 days after vaccination | Percentage of subjects with serious adverse event from inclusion until 28 day after each dose vaccination. | 3 Months |
| Number of Lab Deviation for adults subjects in 7 days of immunization | Number of deviation from routine biochemical (SGOT, SGPT, Ureum, Creatinine) and Hematological (Hb, Hct, Dif, Leucocyte count, Total Leucocyte, total Eryhrocyte, total Thrombocyte) laboratory evaluation that probably related to the vaccination (adults subject). | 7 Days After 1st Vaccination |
| Safety Comparison between each intervention group | incidence of any adverse event, compared between two intervention arms | 3 months |
| Protectivity of Hepatitis B vaccine (number of subject with protective anti HbsAg) | Number of subjects with anti-HbsAg more than 10mIU/ml, 28 days after 1 dose or three doses of vaccination. | 3 months |
| Protectivity of Hepatitis B vaccine (4 times increasing antibody) | - Number and percentage of subjects with more than 4 folds increasing antibody | 3 months |
| Protectivity of Hepatitis B vaccine (Geometic Mean Titers) | - Geometric Mean Titers (GMT) following immunization | 3 months |
| Anti-HBs description between groups | Number of subjects with protective Anti-HBs value, compared between intervention groups after vaccination. | 3 months |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |