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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Single 0.5 mL dose of TCV of EuBiologics co., Ltd.
Single 0.5 mL dose of TCV of Bharat Biotech
Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur
De La Salle Health Sciences Institute
Dasmariñas, Cavite, Philippines
Local and systemic solicited adverse events
Time frame: Day 7
Unsolicited adverse events
Time frame: up to 6 weeks
Serious adverse events
Time frame: up to 6 weeks
Proportion of subjects with seroconversion
Defined as a 4-fold or more rise in anti-Vi antibody titers
Time frame: Baseline to Day 42
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