Typhoid fever
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Clinical Operations Specialist and Clinical Research Manager