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| Name | Class |
|---|---|
| Indonesia University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vi-DT Typhoid Conjugate Vaccine | Experimental | Participants receive 1 dose (0.5ml) Vi-DT Typhoid Conjugate Vaccine, intramuscularly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vi-DT Typhoid Conjugate Vaccine | Drug | Typhoid Conjugate Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years + 2 months after primary dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days (-4/+14D) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernie E Medise, MD | Department of Child Health, School of Medicine, University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puskesmas Jatinegara | Jakarta | Indonesia | ||||
| Puskesmas Senen |
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One dose Vi-DT vaccine in clinical trial subjects which is received primary dose at 6-23 months old.
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| 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. |
| 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. | 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. | 3 years |
| Jakarta |
| Indonesia |