Status:
COMPLETED
Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian
Lead Sponsor:
PT Bio Farma
Collaborating Sponsors:
Indonesia University
Conditions:
Vaccine
Eligibility:
All Genders
6-40 years
Phase:
PHASE2
PHASE3
Brief Summary
Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.
Detailed Description
This study will be done to know the long-term protection and persistent antibody, by measured the antibody titer after 2,3,4 and 5 years after immunization.
Eligibility Criteria
Inclusion
- Healthy.
- Subject who completed the phase II Vi-DT study (Typhoid 0218)
- Subjects/Parents have been informed properly regarding the study and signed the informed consent form.
- Subject/parents/legal guardians will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion
- Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5oC).
- Known history of allergy to any component of the vaccines.
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT04741828
Start Date
May 3 2021
End Date
December 30 2024
Last Update
June 3 2025
Active Locations (2)
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1
Puskesmas Jatinegara
Jakarta, Indonesia
2
Puskesmas Senen
Jakarta, Indonesia