Typhoid Fever
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.
Interventions
BIOLOGICALEuTCV
Single 0.5 mL dose of TCV of EuBiologics co., Ltd.
BIOLOGICALTypbar-TCV™
Single 0.5 mL dose of TCV of Bharat Biotech
BIOLOGICALTyphim Vi®
Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur
Sponsors
EuBiologics Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Healthy adult volunteers will be randomized in a 1:1:1 ratio to receive single dose of test or the comparator vaccines.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects aged between and including 18 and 45 years at time of Visit 1 2. Subjects willing to give written informed consent to participate in the trial 3. Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
Exclusion criteria
1. Subjects unwilling to give his/her consent to participate in the trial 2. Subjects who have received Typhoid containing vaccines 3. Subjects who have past history of Typhoid 4. Subjects already immunized with any licensed vaccine within 4 weeks 5. Subjects with known hypersensitivity to any component of the study vaccine 6. Subjects who are pregnant, lactating or childbearing age not using a reliable method of contraception 7. Subjects with any abnormality or chronic disease 8. Subjects with evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy 9. Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid 10. Subjects who have known history of immune function disorders 11. Subjects who have known history of administration of blood or blood-derived products 12. Subjects who have history of alcohol or substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local and systemic solicited adverse events | Day 7 |
| Unsolicited adverse events | up to 6 weeks |
| Serious adverse events | up to 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with seroconversion | Baseline to Day 42 | Defined as a 4-fold or more rise in anti-Vi antibody titers |
Countries
Philippines
Outcome results
None listed