Protectivity and Safety Following Recombinant Hepatitis B Vaccine
- Conditions
- Immunogenicity
- Interventions
- Biological: Recombinant Hepatitis B vaccineBiological: Recombinant Hepatitis B (Bio Farma)
- Registration Number
- NCT03919578
- Lead Sponsor
- PT Bio Farma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 536
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hep B Batch 3 Recombinant Hepatitis B vaccine 1 dose of 1 mL Hepatitis B Batch 3 Hep B Batch 1 Recombinant Hepatitis B vaccine 1 dose of 1 mL Hepatitis B Batch 1 Hep B Batch 2 Recombinant Hepatitis B vaccine 1 dose of 1 mL Hepatitis B Batch 2 Hep B (Bio Farma) Recombinant Hepatitis B (Bio Farma) 1 dose of 1 mL Hepatitis B (Bio Farma)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
Trial Locations
- Locations (1)
RSND
🇮🇩Semarang, Central Java, Indonesia