Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines (Bio TCV) in Indonesian Population compared to PQed TCV

Tahapan Penelitian : Initial
Sponsor:
Mitra Pelaksana:
Not Specified
No Registry
INA-6NQDMTGP
Tanggal Input Registry : 22-05-2025

01-06-2025
1. Geometric Mean Titre (GMT) of anti-Vi IgG 5 years after Bio-TCV vaccination 2. Number and percentage of subjects with seroconversion defined as ≥ 4-fold in antibody titer of anti-Vi-IgG 5 years after Bio-TCV vaccination. 3. Comparison of GMT and seroconversion of anti-Vi IgG 5 years after Bio-TCV vaccination compared to Typbar vaccination.
 
Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines (Bio TCV) in Indonesian Population compared to PQed TCV
Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines (Bio TCV) in Indonesian Population compared to PQed TCV
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Inclusion Criteria:

1. Healthy. 2. Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form. 3. Subject/parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
 
KET-06/UN2.F1/ETIK/PPM.00.02/2025 dan 1235/KEPK/II/2025
Not applicable
PPUK/PPUB number
Not Specified
Dr. dr. Bernie Endyarni Medise, SpA(K), MPH & Dr. Dominicus Husada, dr., SpA(K)