NCT04051268

Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)

Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to Lot Consistency, Non-inferiority to PQed (Prequalified) TCV (Typhoid Conjugate Vaccine)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,071 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 6 Months – 60 Years
• Healthy volunteers: Accepted

Summary

Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.

Detailed description

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.

Conditions

• Safety Issues
• Immunogenicity

Interventions

Type	Name	Description
BIOLOGICAL	Vi-DT Typhoid Conjugate Vaccine	1 dose of Investigational Product
BIOLOGICAL	PQed Typhoid Conjugate Vaccine	1 dose of Active Comparator
BIOLOGICAL	Vi Polysaccharide Vaccine	1 dose of Active Comparator

Timeline

• Start date: 2020-03-02
• Primary completion: 2021-11-24
• Completion: 2021-12-01
• First posted: 2019-08-09
• Last updated: 2022-01-04

Locations

1 site across 1 country: Indonesia