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

Primary Purpose

Typhoid Fever

Status

Completed

Phase

Phase 2

Locations

Philippines

Study Type

Interventional

Intervention

EuTCV (Vi-CRM Typhoid conjugate vaccine)

Typbar-TCV

About this trial

This is an interventional prevention trial for Typhoid Fever

Eligibility Criteria

6 Months - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

De La Salle Medical and Health Sciences Institute
University of the East Ramon Magsaysay Memorial Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (Vi-CRM197, Batch #1)

Arm A (Vi-CRM197, Batch #2)

Arm A (Vi-CRM197, Batch #3)

Arm D (Typbar-TCV)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Seroconversion rate

Proportion of Solicited local and systemic AEs

Proportion of unsolicited AEs

Secondary Outcome Measures

Full Information

NCT ID

NCT04830371

First Posted

March 31, 2021

Last Updated

October 6, 2021

Sponsor

EuBiologics Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04830371

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

September 7, 2020 (Actual)

Primary Completion Date

March 18, 2021 (Actual)

Study Completion Date

August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EuBiologics Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Typhoid Fever

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

444 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A (Vi-CRM197, Batch #1)

Arm Type

Experimental

Arm Description

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

Arm Title

Arm A (Vi-CRM197, Batch #2)

Arm Type

Experimental

Arm Description

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

Arm Title

Arm A (Vi-CRM197, Batch #3)

Arm Type

Experimental

Arm Description

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

Arm Title

Arm D (Typbar-TCV)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

EuTCV (Vi-CRM Typhoid conjugate vaccine)

Intervention Description

Single dose, Intramuscular administration

Intervention Type

Biological

Intervention Name(s)

Typbar-TCV

Intervention Description

Single dose, Intramuscular administration

Primary Outcome Measure Information:

Title

Seroconversion rate

Time Frame

4 weeks after vaccination of EuTCV (pooled of 3 batches)/Typbar-TCV compared to baseline

Title

Proportion of Solicited local and systemic AEs

Time Frame

7 days after vaccination

Title

Proportion of unsolicited AEs

Time Frame

within 28 days after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

De La Salle Medical and Health Sciences Institute

City

Cavite

Country

Philippines

Facility Name

University of the East Ramon Magsaysay Memorial Medical Center

City

Quezon City

Country

Philippines

12. IPD Sharing Statement

Learn more about this trial

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

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