Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.

Official Title
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An Open-label, Comparative, Clinical Phase 1 Study to Assess the Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

Conditions
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Typhoid Fever

Intervention / Treatment
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* Biological: EuTCV
* Biological: Typbar-TCV™
* Biological: Typhim Vi®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged between and including 18 and 45 years at time of Visit 1 Subjects willing to give written informed consent to participate in the trial Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests Exclusion Criteria: Subjects unwilling to give his/her consent to participate in the trial Subjects who have received Typhoid containing vaccines Subjects who have past history of Typhoid Subjects already immunized with any licensed vaccine within 4 weeks Subjects with known hypersensitivity to any component of the study vaccine Subjects who are pregnant, lactating or childbearing age not using a reliable method of contraception Subjects with any abnormality or chronic disease Subjects with evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid Subjects who have known history of immune function disorders Subjects who have known history of administration of blood or blood-derived products Subjects who have history of alcohol or substance abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Healthy adult volunteers will be randomized in a 1:1:1 ratio to receive single dose of test or the comparator vaccines.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Single dose of EuTCV will be administered intramuscularly | Biological: EuTCV<br>* Single 0.5 mL dose of TCV of EuBiologics co., Ltd.<br>|
| Active Comparator: Comparator group 1<br>Single dose of Typbar-TCV™ will be administered intramuscularly | Biological: Typbar-TCV™<br>* Single 0.5 mL dose of TCV of Bharat Biotech<br>|
| Active Comparator: Comparator group 2<br>Single dose of Typhim Vi® will be administered intramuscularly | Biological: Typhim Vi®<br>* Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and systemic solicited adverse events |  | Day 7 | 
| Unsolicited adverse events |  | up to 6 weeks | 
| Serious adverse events |  | up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with seroconversion | Defined as a 4-fold or more rise in anti-Vi antibody titers | Baseline to Day 42 |