Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and to Typhoid Vi polysaccharide vaccine. Involved participants aged 6 months old to 60 years old.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,071
1 dose of Investigational Product
1 dose of Active Comparator
1 dose of Active Comparator
Jatinegara Primary Health Care
Jakarta, Jakart, Indonesia
Immunogenicity
Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants.
Time frame: 28 days
Describe antibody response following vaccination
Comparison of GMT, seroconversion between each lot number of Vi-DT (Bio Farma ) vaccine in each group.
Time frame: 28 days
Adverse event, solicited or unsolicited
Number and percentage with at least one adverse event, solicited or unsolicited, within 30 minutes, 72 hours, 7 days, and 28 days after vaccination.
Time frame: 28 days
Comparison the safety and immunogenicity
Comparison of adverse events occuring until 28 days after vaccination between each lot number of Vi-DT (Bio Farma ) vaccine and PQed typhoid conjugate vaccine
Time frame: 28 days
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