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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04830371
Other study ID # EuVCT_TCV301
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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