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This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
To describe the safety of this vaccine following one dose immunization in adults, adolescent, children and infants.
To assess immunogenicity following one dose of Vi-DT vaccine immunization. To compare the safety and immunogenicity of Vi-DT to Vi polysaccharide vaccine in adults, adolescents, and children groups.
To compare the safety and immunogenicity of Vi-DT to IPV vaccine in infants groups.
Kinetics of Vi-specific IgG antibodies up to 6 months and 1 year after administration of 1 dose of vaccine.
To evaluate the safety and immunogenicity of Vi-DT co-administered with MR vaccine in infants (≥ 9months -23 months old).
To evaluate the safety and immunogenicity of MR vaccine co-administered with Vi-DT vaccine in infants (≥ 9months -23 months old).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VI-DT vaccine (adults,adolescent) | Experimental | 1 dose of 0.5 ml Vi-DT vaccine |
|
| Vi polysaccharide (adults,adolescent) | Active Comparator | 1 dose of 0.5 ml Vi polysaccharide vaccine |
|
| VI-DT vaccine (children) | Experimental | 1 dose of 0.5 ml Vi-DT vaccine |
|
| Vi polysaccharide vaccine (children) | Active Comparator | 1 dose of 0.5 ml Vi polysaccharide vaccine |
|
| VI-DT vaccine (infants) | Experimental | 1 dose of 0.5 ml Vi-DT vaccine |
|
| IPV Vaccine (infants) | Active Comparator | 1 dose of 0.5 ml IPV vaccine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vi-DT Vaccine | Biological | 1 dose of Vi-DT Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local reaction and systemic event after vaccination | Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events after vaccination | Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after 1 dose vaccination. | up to 28 days |
| Serious adverse events after vaccination |
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Inclusion Criteria:
Exclusion Criteria For adults-adolescent-children:
Exclusion Criteria for infants:
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| Name | Affiliation | Role |
|---|---|---|
| Bernie Endyarni, MD | Faculty of Medicine, University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puskesmas Jatinegara | Jakarta | Indonesia | ||||
| Puskesmas Senen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38297337 | Derived | Koesnoe S, Medise BE, Rengganis I, Hadinegoro SR, Puspita M, Sari RM, Yang JS, Sahastrabuddhe S, Soedjatmiko, Gunardi H, Sekartini R, Wirahmadi A, Kekalih A, Mukhi S, Satari HI, Bachtiar NS. A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity. Trop Dis Travel Med Vaccines. 2024 Feb 1;10(1):3. doi: 10.1186/s40794-023-00210-z. | |
| 33059607 |
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| ID | Term |
|---|---|
| C057664 | Vi polysaccharide vaccine, typhoid |
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Subject aged 2 - 40 years old:
Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine.
Subject aged 6-23 months old:
Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).
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Subject aged 2 - 40 years old:
Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine.
Subject 6-23 months old:
Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).
|
|
| Vi Polysaccharide Vaccine | Biological | 1 dose of Vi Polysaccharide Vaccine |
|
| IPV Vaccine | Biological | 1 dose of IPV Vaccine |
|
Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination
| 28 days |
| Geometric Mean Titers (GMT) | Geometric Mean Titers (GMT) 28 days following immunization | 28 days |
| Percentage of subjects with increasing antibody titer >= 4 times | Percentage of subjects with increasing antibody titer >= 4 times in all subjects | 28 days |
| Jakarta |
| Indonesia |
| Derived |
| Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2-11 years: a phase II preliminary report. BMC Pediatr. 2020 Oct 15;20(1):480. doi: 10.1186/s12887-020-02375-4. |
| 32004693 | Derived | Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. One-month follow up of a randomized clinical trial-phase II study in 6 to <24 months old Indonesian subjects: Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine. Int J Infect Dis. 2020 Apr;93:102-107. doi: 10.1016/j.ijid.2020.01.045. Epub 2020 Jan 28. |