Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants
NCT ID: NCT04830371
Last Updated: 2021-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
444 participants
INTERVENTIONAL
2020-09-07
2021-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Arm A (Vi-CRM197, Batch #1)
Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #1 will be intramuscularly administered at Day 0.
EuTCV (Vi-CRM Typhoid conjugate vaccine)
Single dose, Intramuscular administration
Arm A (Vi-CRM197, Batch #2)
Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #2 will be intramuscularly administered at Day 0.
EuTCV (Vi-CRM Typhoid conjugate vaccine)
Single dose, Intramuscular administration
Arm A (Vi-CRM197, Batch #3)
Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #3 will be intramuscularly administered at Day 0.
EuTCV (Vi-CRM Typhoid conjugate vaccine)
Single dose, Intramuscular administration
Arm D (Typbar-TCV)
Single dose of Typhoid Conjugate Vaccine (Typbar-TCV) will be intramuscularly administered at Day 0.
Typbar-TCV
Single dose, Intramuscular administration
Interventions
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EuTCV (Vi-CRM Typhoid conjugate vaccine)
Single dose, Intramuscular administration
Typbar-TCV
Single dose, Intramuscular administration
Eligibility Criteria
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Inclusion Criteria
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
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
6 Months
45 Years
ALL
Yes
Sponsors
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EuBiologics Co.,Ltd
INDUSTRY
Responsible Party
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Locations
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De La Salle Medical and Health Sciences Institute
Cavite, , Philippines
University of the East Ramon Magsaysay Memorial Medical Center
Quezon City, , Philippines
Countries
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References
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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.
Other Identifiers
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EuVCT_TCV301
Identifier Type: -
Identifier Source: org_study_id
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