Trials / Completed
CompletedNCT03109600
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
A Randomized, Observer Blinded, Comparative, Phase I Safety Study in Two Age De-escalating Cohorts to Assess the Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 2 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
This study is to assess the safety of Vi-DT vaccine in adults and children.
Detailed description
To describe the safety of this vaccine following first and second dose immunization. To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-04-18
- Primary completion
- 2017-09-28
- Completion
- 2018-02-19
- First posted
- 2017-04-12
- Last updated
- 2018-03-06
Locations
2 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT03109600. Inclusion in this directory is not an endorsement.