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This study is to assess the safety of Vi-DT vaccine in adults and children.
To describe the safety of this vaccine following first and second dose immunization.
To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vi-DT (Bio Farma) | Experimental | 2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine |
|
| Vi polysaccharide vaccine | Active Comparator | 1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine |
|
| Vi-DT (Bio Farma) ~ Children | Experimental | 2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine |
|
| Vi polysaccharide vaccine ~ Children | Active Comparator | 1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vi-DT (Bio Farma) | Biological | Typhoid Conjugate 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 each vaccination. | 28 days |
| Serious adverse events after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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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 | DKI Jaya | Indonesia | |||
| Jatinegara Primary Health Center |
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| ID | Term |
|---|---|
| C057664 | Vi polysaccharide vaccine, typhoid |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Vi polysaccharide vaccine | Biological | Vi polysaccharide vaccine |
|
| Influenzae vaccine | Biological | 1 dose of Influenzae vaccine |
|
| Pneumococcal conjugate vaccine | Biological | 1 dose of Pneumococcal conjugate Vaccine |
|
Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination and up to 6 months after the last vaccination.
| 28 days |
| Routine laboratory evaluation that probably related to the vaccination. | Deviation from routine blood laboratory, kidney and liver function laboratory evaluation that probably related to the vaccination. | 7 days |
| Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT) | Percentage of subjects with > 4 times increasing antibody | 28 days |
| Geometric Mean Titers (GMT) following immunization | Geometric Mean Titers (GMT) 28 days following immunization | 28 days |
| Jakarta |
| Indonesia |
| D045424 |
| Complex Mixtures |