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| Name | Class |
|---|---|
| RS Prof. Dr. I.G.N.G Ngoerah | UNKNOWN |
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This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.
This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. A total of 540 subjects will be involved in this study.
The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 1 | Experimental | 3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine |
|
| In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 2 | Experimental | 3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine |
|
| In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 3 | Experimental | 3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine |
|
| Registered Hepatitis B vaccine recombinant (Engerix-B) | Active Comparator | 3 doses Registered Hepatitis B vaccine recombinant (Engerix-B) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-House Recombinant Hepatitis B (Bio Farma) vaccine | Biological | 3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Protectivity | Number & percentage of subjects with anti HBsAg > 10mIU/ml | 28 days after the primary series of Hepatitis B vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: Serological response | Geometric mean of anti-HBsAg, percentage of subjects with increasing antibody titer >= 4 times and/ or percentage of subjects with transition of seronegative to seropositive | 28 days after the primary series of Hepatitis B vaccination |
| Immunogenicity: comparison between IP & control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rini Mulia Sari, MD | Contact | 0222033755 | 14102 | rini.mulia@biofarma.co.id |
| Mita Puspita, MD | Contact | 0222033755 | 5045 | mita.puspita@biofarma.co.id |
| Name | Affiliation | Role |
|---|---|---|
| Trisna Windiani, MD | RSUP Prof. dr. I.G.N.G. Ngoerah | Principal Investigator |
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Experimental, randomized, observer-blind, lot to lot consistency
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The subject will be randomized and vaccinated per treatment group by unblinded team.
The randomization list will be provided by unblinded personel of study team. This unblinded team will keep the list until Bio Farma formally issue the result of the study. Treatment will be allocated in accordance with a randomization list, so that to each randomization number, corresponds only one strictly randomly assigned treatment group (A/B/C/D).
| Registered Hepatitis B vaccine recombinant (Engerix-B) | Biological | 3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B) |
|
Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer >=4 times and/ or percentage of subjects with transition of seronegative to seropositive |
| 28 days after the primary series of Hepatitis B vaccination |
| Immunogenicity: comparison among each batch of IP | Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer >=4 times and/ or percentage of subjects with transition of seronegative to seropositive | 28 days after the primary series of Hepatitis B vaccination |
| Safety: Immediate reaction, Local and systemic events | Immediate reaction, Local and systemic events | within the first 30 minutes, after 30 minutes to 7 days, after 7 days to 28 days after each injection |
| Safety: Serious adverse event | Any serious adverse event | from inclusion until 28 days after the last injection |
| Safety: Comparison of adverse events between Investigational Products (Hepatitis B) and Control | Adverse events occuring until 28 days after vaccination | 28 days after each dose |
| Safety: 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 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| C075654 | Engerix-B |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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