This trial is an experimental, randomized, double blind, prospective intervention study Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow: For adult (18-40 years old)
Each study age group/arm will be divided into two groups of treatment. One group will receive investigational product and one other group will receive active comparator. This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) ). Before the study started, the subjects will be assessed for anti HBs Antibody. For subjects with anti-HBs not protective (\< 10mIU/mL) before immunization, additional 2 doses will be required with 1 month interval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
100
Recombinant Hepatitis B vaccine produced by Bio Farma
Registered Recombinant Hepatitis B vaccine produced by Bio Farma
Hasan Sadikin Hospital
Bandung, West Java, Indonesia
Number of subjects with Immediate reaction
Number of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
Time frame: 3 months
percentage of subjects with Immediate reaction
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
Time frame: 3 months
Number of subjects with Adverse Events from 1 day to 28 days after vaccination
Number of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each dose vaccination
Time frame: 3 months
Percentage of subjects with Adverse Events from 1 day to 28 days after vaccination
Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each dose vaccination
Time frame: 3 months
Number of subjects with Serious Adverse Events from 1 day to 28 days after vaccination
Number of subjects with serious adverse event from inclusion until 28 day after each dose vaccination.
Time frame: 3 Months
Percentage of subjects with serious Adverse Events from 1 day to 28 days after vaccination
Percentage of subjects with serious adverse event from inclusion until 28 day after each dose vaccination.
Time frame: 3 Months
Number of Lab Deviation for adults subjects in 7 days of immunization
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Number of deviation from routine biochemical (SGOT, SGPT, Ureum, Creatinine) and Hematological (Hb, Hct, Dif, Leucocyte count, Total Leucocyte, total Eryhrocyte, total Thrombocyte) laboratory evaluation that probably related to the vaccination (adults subject).
Time frame: 7 Days After 1st Vaccination
Safety Comparison between each intervention group
incidence of any adverse event, compared between two intervention arms
Time frame: 3 months
Protectivity of Hepatitis B vaccine (number of subject with protective anti HbsAg)
Number of subjects with anti-HbsAg more than 10mIU/ml, 28 days after 1 dose or three doses of vaccination.
Time frame: 3 months
Protectivity of Hepatitis B vaccine (4 times increasing antibody)
\- Number and percentage of subjects with more than 4 folds increasing antibody
Time frame: 3 months
Protectivity of Hepatitis B vaccine (Geometic Mean Titers)
\- Geometric Mean Titers (GMT) following immunization
Time frame: 3 months
Anti-HBs description between groups
Number of subjects with protective Anti-HBs value, compared between intervention groups after vaccination.
Time frame: 3 months