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

EuBiologics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Typhoid Fever

Treatments: Biological: Typbar-TCV; Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04830371

EuVCT_TCV301

Details and patient eligibility

About

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.

Enrollment: 444 patients

Sex: All

Ages: 6 months to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy participants ≥6 months and ≤45 years of age at enrolment
2. Participants/Parents/Legally Authorized Representative(LAR) willing to give written informed consent/assent to participate in the trial
3. Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study
4. Participants who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
5. 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

1. Participants/Parents/LAR unwilling to give his/her consent/assent to participate in the trial
2. Participants concomitantly enrolled or scheduled to be enrolled in another trial
3. Children and infants with a congenital abnormality
4. Known history of immune function disorders including immunodeficiency disease, or chronic use of systemic steroids, cytotoxic or other immunosuppressive drugs
5. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
6. History of uncontrolled coagulopathy or blood disorders
7. 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
8. History of alcohol or substance abuse

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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444 participants in 4 patient groups

Arm A (Vi-CRM197, Batch #1)

Experimental group

Description:

Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #1 will be intramuscularly administered at Day 0.

Treatment:

Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)

Arm A (Vi-CRM197, Batch #2)

Experimental group

Description:

Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #2 will be intramuscularly administered at Day 0.

Treatment:

Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)

Arm A (Vi-CRM197, Batch #3)

Experimental group

Description:

Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #3 will be intramuscularly administered at Day 0.

Treatment:

Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)

Arm D (Typbar-TCV)

Active Comparator group

Description:

Single dose of Typhoid Conjugate Vaccine (Typbar-TCV) will be intramuscularly administered at Day 0.

Treatment:

Biological: Typbar-TCV