Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
Primary Purpose
Vaccine Reaction, Vaccine Adverse Reaction
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hepatitis B vaccine lot 1
Hepatitis B vaccine lot 2
Hepatitis B vaccine lot 3
Hepatitis B vaccine (registered)
Sponsored by
About this trial
This is an interventional prevention trial for Vaccine Reaction focused on measuring Hepatitis B vaccine, Vaccine
Eligibility 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 ≥ 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Hepatitis B vaccine lot 1
Hepatitis B vaccine lot 2
Hepatitis B vaccine lot 3
Active Control: Hepatitis B vaccine (registered)
Arm Description
3 doses Recombinant Hepatitis B new Bulk vaccine lot 1
3 doses Recombinant Hepatitis B new Bulk vaccine lot 2
3 doses Recombinant Hepatitis B new Bulk vaccine lot 3
3 doses Recombinant Hepatitis B vaccine (registered)
Outcomes
Primary Outcome Measures
Percentage of subjects with increasing antibody titer >= 4 times
Percentage of subjects with increasing antibody titer >= 4 times: in all subjects;
Secondary Outcome Measures
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
Percentage of subjects with transition of seronegative to seropositive
Percentage of subjects with transition of seronegative to seropositive: in all subjects;
Percentage of subjects with at least one immediate reaction
Immediate reaction (local reaction or systemic event)
Percentage of subjects with at least one of these adverse events
At least one of these adverse events, expected or not
Serious adverse event after vaccination
Serious adverse event occurring from inclusion until 28 days after vaccination.
Comparison adverse events between Investigational Products (Hepatitis B) and Control
Adverse events occuring until 28 days after vaccination
Comparison of adverse events between each lot number of Recombinant Hepatitis B
Adverse events occuring until 28 days after vaccination
Full Information
NCT ID
NCT05482295
First Posted
July 29, 2022
Last Updated
September 15, 2022
Sponsor
PT Bio Farma
Collaborators
RS Umum Pusat Sanglah, Denpasar
1. Study Identification
Unique Protocol Identification Number
NCT05482295
Brief Title
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
Official Title
Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Hepatitis B (Bio Farma)® Vaccine in Indonesian Population
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT Bio Farma
Collaborators
RS Umum Pusat Sanglah, Denpasar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine Reaction, Vaccine Adverse Reaction
Keywords
Hepatitis B vaccine, Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hepatitis B vaccine lot 1
Arm Type
Experimental
Arm Description
3 doses Recombinant Hepatitis B new Bulk vaccine lot 1
Arm Title
Hepatitis B vaccine lot 2
Arm Type
Experimental
Arm Description
3 doses Recombinant Hepatitis B new Bulk vaccine lot 2
Arm Title
Hepatitis B vaccine lot 3
Arm Type
Experimental
Arm Description
3 doses Recombinant Hepatitis B new Bulk vaccine lot 3
Arm Title
Active Control: Hepatitis B vaccine (registered)
Arm Type
Active Comparator
Arm Description
3 doses Recombinant Hepatitis B vaccine (registered)
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccine lot 1
Intervention Description
3 doses of Hepatitis B vaccine lot 1
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccine lot 2
Intervention Description
3 doses of Hepatitis B vaccine lot 2
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccine lot 3
Intervention Description
3 doses of Hepatitis B vaccine lot 3
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccine (registered)
Intervention Description
3 doses of Hepatitis B vaccine (registered)
Primary Outcome Measure Information:
Title
Percentage of subjects with increasing antibody titer >= 4 times
Description
Percentage of subjects with increasing antibody titer >= 4 times: in all subjects;
Time Frame
28 days after the last dose immunization
Secondary Outcome Measure Information:
Title
Geometric Mean Titer (GMT)
Description
GMT in all subjects; comparison of GMT between investigational products and control and comparison of GMT between each lot number of Recombinant Hepatitis B
Time Frame
28 days after the last dose immunization
Title
Percentage of subjects with transition of seronegative to seropositive
Description
Percentage of subjects with transition of seronegative to seropositive: in all subjects;
Time Frame
28 days after the last dose immunization
Title
Percentage of subjects with at least one immediate reaction
Description
Immediate reaction (local reaction or systemic event)
Time Frame
30 minutes after each vaccination
Title
Percentage of subjects with at least one of these adverse events
Description
At least one of these adverse events, expected or not
Time Frame
within 72 hours, between 72 hours to 28 days after vaccination
Title
Serious adverse event after vaccination
Description
Serious adverse event occurring from inclusion until 28 days after vaccination.
Time Frame
28 days after the last dose immunization
Title
Comparison adverse events between Investigational Products (Hepatitis B) and Control
Description
Adverse events occuring until 28 days after vaccination
Time Frame
28 days after each dose
Title
Comparison of adverse events between each lot number of Recombinant Hepatitis B
Description
Adverse events occuring until 28 days after vaccination
Time Frame
28 days after each dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 ≥ 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rini Mulia Sari, MD
Phone
0222033755
Ext
14102
Email
rini.mulia@biofarma.co.id
First Name & Middle Initial & Last Name or Official Title & Degree
Mita Puspita, MD
Phone
0222033755
Ext
5045
Email
mita.puspita@biofarma.co.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trisna Windiani, MD
Organizational Affiliation
RS Umum Pusat Sanglah
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
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