Immunogenicity
Conditions
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.
Interventions
BIOLOGICALRecombinant 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.
BIOLOGICALRecombinant 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.
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Investigational product was masking with control
Intervention model description
Experimental, randomized, double blind, four arm parallel group study
Eligibility
Sex/Gender
ALL
Age
10 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form. 3. Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion criteria
1. Subject concomitantly enrolled or scheduled to be enrolled in another trial. 2. Subjects with known history of Hepatitis B contained vaccination in the last 10 years 3. Evolving severe illness and/or chronic disease and fever (axillary temperature more than37.5oC) within the 48 hours preceding enrollment. 4. Known history of allergy to any component of the vaccines (based on anamnesis) 5. HBsAg positive 6. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy). 7. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 8. 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. 9. Pregnancy & Lactation (Adult) 10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with increasing antibody titer >= 4 times | 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
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) | 28 days after the last dose immunization | 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 | 28 days after the last dose immunization | 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 | 30 minutes after each vaccination | Immediate reaction (local reaction or systemic event) |
| Percentage of subjects with at least one of these adverse events | 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 | 28 days after the last dose immunization | Serious adverse event occurring from inclusion until 28 days after vaccination. |
| Comparison adverse events between Investigational Products (Hepatitis B) and Control | 28 days after each dose | Adverse events occuring until 28 days after vaccination |
| Comparison of adverse events between each lot number of Recombinant Hepatitis B vaccine | 28 days after each dose | Adverse events occuring until 28 days after vaccination |
Countries
Indonesia
Outcome results
None listed