Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Immunogenicity
- Safety Issues
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects 6 months - 45 years of age: Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine Subjects 46 - 60 years of age: Randomized, observer blind, lot to lot consistency, superiority to Vi polysaccharide vaccine. Subjects 6 months - 60 years old: Randomized, observer blind, lot to lot consistencyMasking: Double (Participant, Investigator)Masking Description: Investigational Product and Active Comparator was masking Number of lot was maskingPrimary Purpose: Prevention
Participation Requirements
- Age
- Younger than 660 years
- Gender
- Both males and females
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.
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.
Tracking Information
- NCT #
- NCT04051268
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Bernie E Medise, MD Fakultas Kedokteran Universitas Indonesia
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