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

Typhoid Fever Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04830371
• Other study ID #: EuVCT_TCV301
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 7, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2021
• Source: EuBiologics Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: August 1, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Typhoid Fever

Intervention

Biological:
• EuTCV (Vi-CRM Typhoid conjugate vaccine)
Single dose, Intramuscular administration
• Typbar-TCV
Single dose, Intramuscular administration

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
EuBiologics Co.,Ltd

Country where clinical trial is conducted

Philippines, 

Outcome

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