Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
NCT03109600 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2018-03-06
Summary
This study is to assess the safety of Vi-DT vaccine in adults and children.
Conditions
- Safety Issues
Interventions
- BIOLOGICAL
-
Vi-DT (Bio Farma)
Typhoid Conjugate Vaccine
- BIOLOGICAL
-
Vi polysaccharide vaccine
Vi polysaccharide vaccine
- BIOLOGICAL
-
Influenzae vaccine
1 dose of Influenzae vaccine
- BIOLOGICAL
-
Pneumococcal conjugate vaccine
1 dose of Pneumococcal conjugate Vaccine
Sponsors & Collaborators
-
PT Bio Farma
lead INDUSTRY
Principal Investigators
-
Bernie Endyarni, MD · Faculty of Medicine, University of Indonesia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-04-18
- Primary Completion
- 2017-09-28
- Completion
- 2018-02-19
Countries
- Indonesia
Study Locations
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