CompletedNCT04830371Updated Oct 7, 2021

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

A Phase 2/3 interventional study of EuTCV (Vi-CRM Typhoid conjugate vaccine) and Typbar-TCV in Typhoid Fever, sponsored by EuBiologics Co.,Ltd. Completed at 2 sites in Philippines. Open to participants aged 6 Months to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-07.

Sponsored by EuBiologics Co.,Ltd · Phase 2/3, Interventional, and Prevention

From the registry’s dates

Registered 6 months after the study started (first participant enrolled Sep 2020, registered Mar 2021).

Phase: Phase 2/3
Study type: Interventional
Enrollment: 444
Allocation: Randomized
Ages: 6 Months to 45 Years
Sex: All

Study 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.

Conditions studied

Typhoid Fever

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Typhoid Fever 74

In context

Typhoid Fever

74 studies on the registry are indexed under Typhoid Fever; 10 are open to participants now.

This study's enrollment of 444 is above the median of 149 across 64 interventional studies indexed under Typhoid Fever.

Browse Typhoid Fever studies →

Lead sponsor

EuBiologics Co.,Ltd is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Months to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 444 participants (actual)

Study arms

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)
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)
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)
Active comparator
Arm D (Typbar-TCV)
Single dose of Typhoid Conjugate Vaccine (Typbar-TCV) will be intramuscularly administered at Day 0.
Biological: Typbar-TCV

Interventions

BiologicalEuTCV (Vi-CRM Typhoid conjugate vaccine)
Single dose, Intramuscular administration
BiologicalTypbar-TCV
Single dose, Intramuscular administration

What researchers measure

Primary outcomes

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

Study locations

2 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04830371
Lead sponsor: EuBiologics Co.,Ltd
Responsible party: Sponsor
First posted: Apr 5, 2021
Start date: Sep 7, 2020
Primary completion: Mar 18, 2021
Completion: Aug 1, 2021
Last update: Oct 7, 2021

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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