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
Qualifiers
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
Treatments tested in this trial
- In-House Recombinant Hepatitis B (Bio Farma) vaccine
- Registered Hepatitis B vaccine recombinant (Engerix-B)
Treatment groups
540 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
PT Bio Farma
Lead sponsor
RS Prof. Dr. I.G.N.G Ngoerah
Collaborator
Source ClinicalTrials.gov