Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants
Phase 2
Completed
- Conditions
- Typhoid Fever
- Interventions
- Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)Biological: Typbar-TCV
- Registration Number
- NCT04830371
- Lead Sponsor
- EuBiologics Co.,Ltd
- 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 participants aged 6 months to 45 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 444
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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A (Vi-CRM197, Batch #2) EuTCV (Vi-CRM Typhoid conjugate vaccine) Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #2 will be intramuscularly administered at Day 0. Arm A (Vi-CRM197, Batch #1) EuTCV (Vi-CRM Typhoid conjugate vaccine) Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #1 will be intramuscularly administered at Day 0. Arm D (Typbar-TCV) Typbar-TCV Single dose of Typhoid Conjugate Vaccine (Typbar-TCV) will be intramuscularly administered at Day 0. Arm A (Vi-CRM197, Batch #3) EuTCV (Vi-CRM Typhoid conjugate vaccine) Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #3 will be intramuscularly administered at Day 0.
- Primary Outcome Measures
Name Time Method Proportion of Solicited local and systemic AEs 7 days after vaccination Seroconversion rate 4 weeks after vaccination of EuTCV (pooled of 3 batches)/Typbar-TCV compared to baseline Proportion of unsolicited AEs within 28 days after vaccination
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of the East Ramon Magsaysay Memorial Medical Center
🇵🇭Quezon City, Philippines
De La Salle Medical and Health Sciences Institute
🇵🇭Cavite, Philippines