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:
PT Bio Farma
Mitra Pelaksana:
Not Specified
No Registry
INA-6NQDMTGP
Tanggal Input Registry : 22-05-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-06-2025 |
| Outcome Primer | 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. |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines (Bio TCV) in Indonesian Population compared to PQed TCV |
| Judul Penelitian Ilmiah | Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines (Bio TCV) in Indonesian Population compared to PQed TCV |
| Jenis Penelitian | |
| Intervensi | |
| Jumlah Subyek Penelitian | 624 |
| Recruitment Information | |
| Eligibility Criteria | 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. |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-06/UN2.F1/ETIK/PPM.00.02/2025 dan 1235/KEPK/II/2025 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | Not Specified |
| Contact Person | Dr. dr. Bernie Endyarni Medise, SpA(K), MPH & Dr. Dominicus Husada, dr., SpA(K) |