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Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and to Typhoid Vi polysaccharide vaccine.
Involved participants aged 6 months old to 60 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vi-DT TCV Batch 1 | Experimental | 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 1 |
|
| Vi-DT TCV Batch 2 | Experimental | 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 2 |
|
| Vi-DT TCV Batch 3 | Experimental | 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 3 |
|
| PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo) | Active Comparator | 1 dose of 0.5 ml of PQed TCV Vaccine |
|
| Vi Polysaccharide Vaccine (subjects 46-60 years old) | Active Comparator | 1 dose of 0.5 ml of Vi Polysaccharide Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vi-DT Typhoid Conjugate Vaccine | Biological | 1 dose of Investigational Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Describe antibody response following vaccination | Comparison of GMT, seroconversion between each lot number of Vi-DT (Bio Farma ) vaccine in each group. | 28 days |
| Adverse event, solicited or unsolicited |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernie E Medise, MD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jatinegara Primary Health Care | Jakarta | Jakart | Indonesia |
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| ID | Term |
|---|---|
| C057664 | Vi polysaccharide vaccine, typhoid |
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Subjects 6 months - 45 years of age: Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine Subjects 46 - 60 years of age: Randomized, observer blind, lot to lot consistency, superiority to Vi polysaccharide vaccine.
Subjects 6 months - 60 years old: Randomized, observer blind, lot to lot consistency
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Investigational Product and Active Comparator was masking Number of lot was masking
| PQed Typhoid Conjugate Vaccine | Biological | 1 dose of Active Comparator |
|
| Vi Polysaccharide Vaccine | Biological | 1 dose of Active Comparator |
|
Number and percentage with at least one adverse event, solicited or unsolicited, within 30 minutes, 72 hours, 7 days, and 28 days after vaccination.
| 28 days |
| Comparison the safety and immunogenicity | Comparison of adverse events occuring until 28 days after vaccination between each lot number of Vi-DT (Bio Farma ) vaccine and PQed typhoid conjugate vaccine | 28 days |