This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
K.E.M. Hospital Research Centre
Pune, Maharashtra, India
The Aga Khan University Hospital
Karachi, Pakistan
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer
Time frame: At 28 days after last vaccination as compared to baseline
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
Time frame: At 6 months after last vaccination as compared to baseline
Anti-Vi ELISA Geometric Mean Concentration (GMC)
Time frame: At 28 days after last vaccination
Anti-Vi ELISA GMC
Time frame: At 6 months after last vaccination
Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination
Solicited local reactions were: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site. Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever. Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants).
Time frame: During the 7-day follow-up period after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.