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CVIA 113 - Observational study to evaluate long-term immune persistance of EuTCV vaccine administered in Senagalese children on CVIA092 study

An open label, observational study to evaluate long- term immune persistence at 3-3.5 years of EuTCV vaccine in Senegalese children who received the vaccine between 9 and 12 months of age in CVIA 092 study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202605522385822
Enrollment
465
Registered
2026-05-15
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Typhoid fever

Interventions

Sponsors

EuBiologics Co. Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, an individual must meet all the following criteria: 1. Parents/ guardians willing and able to provide written informed consent for the participants and willing to comply with study requirements. 2. Healthy male or female participants enrolled in the immunogenicity subset (Cohort 3) of the CVIA 092 study who completed study follow-up. Healthy, as defined by the absence of any clinically significant medical conditions, either acute or chronic, as determined by medical history, screening assessments including physical examination and clinical assessment of the Investigator. 3. Anti-Vi assay results from Day 1 of CVIA 092 (pre vaccination).

Exclusion criteria

Exclusion criteria: An individual who meets any of the following criteria will be excluded from participating in this study: 1. History of typhoid (confirmed either serologically or microbiologically) 2. History of vaccination against typhoid fever after completion of the CVIA 092 study 3. Any ongoing clinically significant systemic disorder 4. Any immunological disorder, coagulation disorder or thrombocytopenia 5. Any ongoing anticoagulant, immunosuppressive or immunostimulant therapy 6. History of administration of blood, blood products or immunoglobulins within past 3 months 7. Participation in another vaccine clinical trial within past 3 months 8. Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled, or could interfere with the evaluation of the study vaccine.

Design outcomes

Primary

MeasureTime frame
Seroconversion rates (=4-fold rise from baseline) of anti-Vi IgG ELISA titers at 3-3.5 years after a single vaccination of EuTCV single-dose vial formulation, EuTYPH-C® multi-dose vial formulation, or Typbar TCV

Secondary

MeasureTime frame
GMTs of anti-Vi IgG antibodies at 3-3.5 years after a single vaccination of EuTCV single-dose vial formulation, EuTYPH-C® multi-dose vial formulation, or Typbar TCV®

Countries

Senegal

Contacts

Public ContactNiles Eaton

Clinical Operations Specialist and Clinical Research Manager

neaton@path.org+12066963576

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026