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出境医 / 临床实验 / Protectivity and Safety Following Recombinant Hepatitis B Vaccine
Protectivity and Safety Following Recombinant Hepatitis B Vaccine
Study Description
Brief Summary:
Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Immunogenicity | Biological: Recombinant Hepatitis B vaccine Biological: Recombinant Hepatitis B (Bio Farma) | Phase 2 Phase 3 |
Detailed Description:
Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population.
Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 536 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Experimental, randomized, double blind, four arm parallel group study |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Investigational product was masking with control |
| Primary Purpose: | Prevention |
| Official Title: | Protectivity and Safety Following Recombinant Hepatitis B Vaccine With Different Source of Hepatitis B Bulk Compared to Hepatitis B (Bio Farma) Vaccine in Indonesian Population |
| Actual Study Start Date : | September 11, 2019 |
| Actual Primary Completion Date : | January 30, 2020 |
| Actual Study Completion Date : | February 28, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Hep B Batch 1
1 dose of 1 mL Hepatitis B Batch 1
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Biological: Recombinant Hepatitis B vaccine
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. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.
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Experimental: Hep B Batch 2
1 dose of 1 mL Hepatitis B Batch 2
|
Biological: Recombinant Hepatitis B vaccine
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. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.
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Experimental: Hep B Batch 3
1 dose of 1 mL Hepatitis B Batch 3
|
Biological: Recombinant Hepatitis B vaccine
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. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.
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|
Active Comparator: Hep B (Bio Farma)
1 dose of 1 mL Hepatitis B (Bio Farma)
|
Biological: Recombinant Hepatitis B (Bio Farma)
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. The inactivated HbsAg (bulk) is imported from The Janssen Vaccine Corp and then formulated and filled at Bio Farma.
|
Outcome Measures
Primary Outcome Measures :
- Percentage of subjects with increasing antibody titer >= 4 times [ Time Frame: 28 days after the last dose immunization ]Percentage of subjects with increasing antibody titer >= 4 times: in all subjects; comparison between investigational product and control and between each lot number of Recombinant Hepatitis B
Secondary Outcome Measures :
- Geometric Mean Titer (GMT) [ Time Frame: 28 days ]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 [ Time Frame: after dosing ]Percentage of subjects with transition of seronegative to seropositive: in all subjects; Subjets which get investigational products and control and each lot number of Recombinant Hepatitis B
- Percentage of subjects with at least one immediate reaction [ Time Frame: 30 minutes after each vaccination ]Immediate reaction (local reaction or systemic event)
- Percentage of subjects with at least one of these adverse events [ Time Frame: 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 [ Time Frame: 28 days ]Serious adverse event occurring from inclusion until 28 days after vaccination.
- Comparison adverse events between Investigational Products (Hepatitis B) and Control [ Time Frame: 28 days ]Adverse events occuring until 28 days after vaccination
- Comparison of adverse events between each lot number of Recombinant Hepatitis B vaccine [ Time Frame: 28 days ]Adverse events occuring until 28 days after vaccination
Eligibility Criteria
| Ages Eligible for Study: | 10 Years to 40 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 more than37.5oC) 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.
Contacts and Locations
Locations
| Indonesia | |
| RSND | |
| Semarang, Central Java, Indonesia | |
Sponsors and Collaborators
PT Bio Farma
Investigators
| Principal Investigator: | Yetty M Nency, MD | Universitas Diponegoro |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 11, 2019 | ||||
| First Posted Date ICMJE | April 18, 2019 | ||||
| Last Update Posted Date | April 1, 2020 | ||||
| Actual Study Start Date ICMJE | September 11, 2019 | ||||
| Actual Primary Completion Date | January 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of subjects with increasing antibody titer >= 4 times [ Time Frame: 28 days after the last dose immunization ] Percentage of subjects with increasing antibody titer >= 4 times: in all subjects; comparison between investigational product and control and between each lot number of Recombinant Hepatitis B
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Protectivity and Safety Following Recombinant Hepatitis B Vaccine | ||||
| Official Title ICMJE | Protectivity and Safety Following Recombinant Hepatitis B Vaccine With Different Source of Hepatitis B Bulk Compared to Hepatitis B (Bio Farma) Vaccine in Indonesian Population | ||||
| Brief Summary | Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population | ||||
| Detailed Description |
Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population. Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Experimental, randomized, double blind, four arm parallel group study Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Investigational product was masking with control Primary Purpose: Prevention
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| Condition ICMJE | Immunogenicity | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
536 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | February 28, 2020 | ||||
| Actual Primary Completion Date | January 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 10 Years to 40 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Indonesia | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03919578 | ||||
| Other Study ID Numbers ICMJE | Hep B 0218 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | PT Bio Farma | ||||
| Study Sponsor ICMJE | PT Bio Farma | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | PT Bio Farma | ||||
| Verification Date | March 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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