NCT04830371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

October 7, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 31, 2021

Last Update Submit

October 6, 2021

Conditions

Typhoid Fever

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (4)

Arm A (Vi-CRM197, Batch #1)

EXPERIMENTAL

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

Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)

Arm A (Vi-CRM197, Batch #2)

EXPERIMENTAL

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

Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)

Arm A (Vi-CRM197, Batch #3)

EXPERIMENTAL

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

Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)

Arm D (Typbar-TCV)

ACTIVE COMPARATOR

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

Biological: Typbar-TCV

Interventions

EuTCV (Vi-CRM Typhoid conjugate vaccine)BIOLOGICAL

Single dose, Intramuscular administration

Arm A (Vi-CRM197, Batch #1)Arm A (Vi-CRM197, Batch #2)Arm A (Vi-CRM197, Batch #3)
Typbar-TCVBIOLOGICAL

Single dose, Intramuscular administration

Arm D (Typbar-TCV)

Eligibility Criteria

Age6 Months - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

De La Salle Medical and Health Sciences Institute

Cavite, Philippines

Location

University of the East Ramon Magsaysay Memorial Medical Center

Quezon City, Philippines

Location

Related Publications (1)

  • Ok Baik Y, Lee Y, Lee C, Kyung Kim S, Park J, Sun M, Jung D, Young Jang J, Jun Yong T, Woo Park J, Jeong S, Lim S, Hyun Han S, Keun Choi S. A Phase II/III, Multicenter, Observer-blinded, Randomized, Non-inferiority and Safety, study of typhoid conjugate vaccine (EuTCV) compared to Typbar-TCV(R) in healthy 6 Months-45 years aged participants. Vaccine. 2023 Mar 3;41(10):1753-1759. doi: 10.1016/j.vaccine.2022.12.007. Epub 2023 Feb 9.

    PMID: 36774331DERIVED

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella InfectionsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

September 7, 2020

Primary Completion

March 18, 2021

Study Completion

August 1, 2021

Last Updated

October 7, 2021

Record last verified: 2021-03

Locations

PH(2)