A Phase 2/3 interventional study of Vi-DT Typhoid Conjugate Vaccine in Vaccine, sponsored by PT Bio Farma. Completed at 2 sites in Indonesia. Open to participants aged 6 Months to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by PT Bio Farma · Phase 2/3, Interventional, and Prevention
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.
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.
PT Bio Farma is the lead sponsor of 44 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive 1 dose (0.5ml) Vi-DT Typhoid Conjugate Vaccine, intramuscularly.
Drug: Vi-DT Typhoid Conjugate Vaccine
Typhoid Conjugate Vaccine
To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants
Percentage of adults, adolescent, children and infants with seroconversion defined as \>= 4 fold in antibody titer of anti Vi IgG 2 years after vaccination compared to baseline.
Time frame: 2 years + 2 months after primary dose
To evaluate immunogenicity one month after booster dose of Vi-DT in subject aged 6-23 months when receiving the primary dose.
Percentage of subject aged 6-23 months old at primary dose with seroconversion defined as \>= 4 fold in antibody titer 28 days after booster dose compared to pre booster dose.
Time frame: 28 days (-4/+14D)
To assess the safety following booster vaccination in subject aged 6-23 months when receiving the primary dose.
Percentage of subject with at least one adverse event, solicited or unsolicited, within 30 minutes, 72hours, 7 days and 28 days after booster dose.
Time frame: 28 days (-4/+14D)
To evaluate antibody persistence 3, 4 and 5 years after vaccination with one dose of Vi-DT in adults, adolescents, and children groups.
Percentage of adults, adolescents and children with seroconversion defined as ≥ 4-fold in antibody titer of anti-Vi IgG 3,4 and 5 years after vaccination compared to baseline.
Time frame: 5 years
To evaluate antibody persistence 1, 2 and 3 years after booster vaccination in subject aged 6-23 months when receiving the primary dose.
Percentage of adults, adolescents and children with seroconversion defined as ≥ 4-fold in antibody titer of anti-Vi IgG 3,4 and 5 years after vaccination compared to before booster.
Time frame: 3 years
Plan to share: No
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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PT Bio Farma