Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants

Study Overview
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Brief Summary
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This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.

Official Title
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A Phase II/III, Multicenter, Observer-Blinded, Randomized, Non-inferiority and Safety Study of Typhoid Conjugate Vaccine (EuTCV) Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants

Conditions
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Typhoid Fever

Intervention / Treatment
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* Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)
* Biological: Typbar-TCV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants ≥6 months and ≤45 years of age at enrolment Participants/Parents/Legally Authorized Representative(LAR) willing to give written informed consent/assent to participate in the trial Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study Participants who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests Female participants must have a negative serum (at Screening) and negative urinary (at Day 1) pregnancy test and agree to use 2 methods of contraception from dosing until 90 days after vaccination. Exclusion Criteria: Participants/Parents/LAR unwilling to give his/her consent/assent to participate in the trial Participants concomitantly enrolled or scheduled to be enrolled in another trial Children and infants with a congenital abnormality Known history of immune function disorders including immunodeficiency disease, or chronic use of systemic steroids, cytotoxic or other immunosuppressive drugs Pregnant, lactating women or women of childbearing age not using a reliable method of contraception History of uncontrolled coagulopathy or blood disorders Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the trial objectives History of alcohol or substance abuse

Ages Eligible for Study
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Minimum Age: 6 Months
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (Vi-CRM197, Batch #1)<br>Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #1 will be intramuscularly administered at Day 0. | Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)<br>* Single dose, Intramuscular administration<br>|
| Experimental: Arm A (Vi-CRM197, Batch #2)<br>Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #2 will be intramuscularly administered at Day 0. | Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)<br>* Single dose, Intramuscular administration<br>|
| Experimental: Arm A (Vi-CRM197, Batch #3)<br>Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #3 will be intramuscularly administered at Day 0. | Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)<br>* Single dose, Intramuscular administration<br>|
| Active Comparator: Arm D (Typbar-TCV)<br>Single dose of Typhoid Conjugate Vaccine (Typbar-TCV) will be intramuscularly administered at Day 0. | Biological: Typbar-TCV<br>* Single dose, Intramuscular administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate |  | 4 weeks after vaccination of EuTCV (pooled of 3 batches)/Typbar-TCV compared to baseline | 
| Proportion of Solicited local and systemic AEs |  | 7 days after vaccination | 
| Proportion of unsolicited AEs |  | within 28 days after vaccination |