Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-50
SponsorPT Bio Farma
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
In-House Recombinant Hepatitis B (Bio Farma) vaccine
Biological/Vaccine3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
Registered Hepatitis B vaccine recombinant (Engerix-B)
Biological/Vaccine3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)
Treatment groups
540 Participants
are divided into 4 treatment groupsGroup A: In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 1Experimental treatment 1 intervention
Group B: In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 2Experimental treatment 1 intervention
Group C: In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 3Experimental treatment 1 intervention
Group D: Registered Hepatitis B vaccine recombinant (Engerix-B)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Protectivity
Number \& percentage of subjects with anti HBsAg \> 10mIU/ml
Time frame
28 days after the primary series of Hepatitis B vaccinationSecondary outcomes
1
Immunogenicity: Serological response
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
Time frame
28 days after the primary series of Hepatitis B vaccination2
Immunogenicity: comparison between IP & control
Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \>=4 times and/ or percentage of subjects with transition of seronegative to seropositive
Time frame
28 days after the primary series of Hepatitis B vaccination3
Immunogenicity: comparison among each batch of IP
Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \>=4 times and/ or percentage of subjects with transition of seronegative to seropositive
Time frame
28 days after the primary series of Hepatitis B vaccination4
Safety: Immediate reaction, Local and systemic events
Immediate reaction, Local and systemic events
Time frame
within the first 30 minutes, after 30 minutes to 7 days, after 7 days to 28 days after each injectionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
PT Bio Farma
Lead sponsor
RS Prof. Dr. I.G.N.G Ngoerah
Collaborator
Source ClinicalTrials.gov
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