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

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

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.

Study Overview

• Status: Completed
• Conditions: Typhoid Fever
• Intervention / Treatment: Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine); Biological: Typbar-TCV

• Study Type: Interventional
• Enrollment (Actual): 444
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Philippines
  • Cavite, Philippines
    • De La Salle Medical and Health Sciences Institute
  • Quezon City, Philippines
    • University of the East Ramon Magsaysay Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: EuBiologics Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Actual): March 18, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Salmonella Infections; Typhoid Fever
• Other Study ID Numbers: EuVCT_TCV301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No