This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
50
1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
Center for the Evaluation of Vaccination (CEV)
Antwerp, Wilrijk (Antwerp), Belgium
Number of Subjects Reporting Any Post Immunization Reactions
Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.
Time frame: During the 7-day period after vaccination
Number of Subjects Reporting Adverse Events
Time frame: During the 28-day period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: During the 6-month period after vaccination
Anti-Vi ELISA Geometric Mean Concentration (GMC)
Time frame: At 28 days after vaccination
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