Status:
COMPLETED
Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants
Lead Sponsor:
EuBiologics Co.,Ltd
Conditions:
Typhoid Fever
Eligibility:
All Genders
6-45 years
Phase:
PHASE2
PHASE3
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 participan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT04830371
Start Date
September 7 2020
End Date
August 1 2021
Last Update
October 7 2021
Active Locations (2)
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1
De La Salle Medical and Health Sciences Institute
Cavite, Philippines
2
University of the East Ramon Magsaysay Memorial Medical Center
Quezon City, Philippines