Immunogenicity and Safety of Typhoid Conjugate Vaccine in Healthy Indian Subjects: A Randomized, Active-controlled, Comparative Clinical Trial

OBJECTIVE To compare the immunogenicity and safety of an investigational typhoid Vi conjugate vaccine (Test TCV) with a marketed typhoid Vi conjugate vaccine (Comparator TCV). DESIGN Randomized, controlled trial. SETTING Tertiary care and multispecialty hospitals. PARTICIPANTS 240 healthy subjects of 6 months to 45 years. Pediatric ( 0.05 for all). The most common adverse event was injection-site pain followed by fever in both the groups. CONCLUSIONS The immunogenicity and safety of test TCV is comparable to already marketed comparator TCV.