Vaccine Adverse Reaction, Vaccine Reaction
Conditions
Keywords
Hepatitis B vaccine, Vaccine
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALIn-House Recombinant Hepatitis B (Bio Farma) vaccine
3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
BIOLOGICALRegistered Hepatitis B vaccine recombinant (Engerix-B)
3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)
Sponsors
RS Prof. Dr. I.G.N.G Ngoerah
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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).
Intervention model description
Experimental, randomized, observer-blind, lot to lot consistency
Eligibility
Sex/Gender
ALL
Age
10 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy individual aged 10 - 50 years old, 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 \>= 37.5 C) 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 immunosuppressant. 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 |
|---|---|---|
| Protectivity | 28 days after the primary series of Hepatitis B vaccination | Number & percentage of subjects with anti HBsAg \> 10mIU/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity: comparison between IP & control | 28 days after the primary series of Hepatitis B vaccination | Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \>=4 times and/ or percentage of subjects with transition of seronegative to seropositive |
| Immunogenicity: comparison among each batch of IP | 28 days after the primary series of Hepatitis B vaccination | Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \>=4 times and/ or percentage of subjects with transition of seronegative to seropositive |
| Safety: 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 | Immediate reaction, Local and systemic events |
| Immunogenicity: Serological response | 28 days after the primary series of Hepatitis B vaccination | 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 |
| Safety: Comparison of adverse events between Investigational Products (Hepatitis B) and Control | 28 days after each dose | Adverse events occuring until 28 days after vaccination |
| Safety: Comparison of adverse events between each lot number of Recombinant Hepatitis B | 28 days after each dose | Adverse events occuring until 28 days after vaccination |
| Safety: Serious adverse event | from inclusion until 28 days after the last injection | Any serious adverse event |
Contacts
Primary ContactRini Mulia Sari, MD
Backup ContactMita Puspita, MD
Outcome results
None listed