Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

Study Overview
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Brief Summary
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This study is to assess the safety of Vi-DT vaccine in adults and children.

Detailed Description
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To describe the safety of this vaccine following first and second dose immunization. To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.

Official Title
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A Randomized, Observer Blinded, Comparative, Phase I Safety Study in Two Age De-escalating Cohorts to Assess the Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

Conditions
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Safety Issues

Intervention / Treatment
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* Biological: Vi-DT (Bio Farma)
* Biological: Vi polysaccharide vaccine
* Biological: Influenzae vaccine
* Biological: Pneumococcal conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Subjects/Parents have been informed properly regarding the study and signed the informed consent form Subject/Parents will commit to comply with the instructions of the investigator and the schedule of the trial Exclusion Criteria: Subject concomitantly enrolled or scheduled to be enrolled in another trial Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C ) Known history of allergy to any component of the vaccines History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks). Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives Pregnancy & lactation (Adults) Individuals who have previously received any vaccines against typhoid fever. Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose. Individuals who have a previously ascertained typhoid fever. History of alcohol or substance abuse. Subject planning to move from the study area before the end of study period.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vi-DT (Bio Farma)<br>2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine | Biological: Vi-DT (Bio Farma)<br>* Typhoid Conjugate Vaccine<br>|
| Active Comparator: Vi polysaccharide vaccine<br>1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine | Biological: Vi polysaccharide vaccine<br>* Vi polysaccharide vaccine<br>Biological: Influenzae vaccine<br>* 1 dose of Influenzae vaccine<br>|
| Experimental: Vi-DT (Bio Farma)   Children<br>2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine | Biological: Vi-DT (Bio Farma)<br>* Typhoid Conjugate Vaccine<br>|
| Active Comparator: Vi polysaccharide vaccine   Children<br>1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine | Biological: Vi polysaccharide vaccine<br>* Vi polysaccharide vaccine<br>Biological: Pneumococcal conjugate vaccine<br>* 1 dose of Pneumococcal conjugate Vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |