Trials / Completed
CompletedNCT03462108
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
A Prospective Intervention Phase I Study in Three Age De-escalating Group to Assess the Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 1 Minute – 40 Years
- Healthy volunteers
- Accepted
Summary
This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
Detailed description
To describe the safety of this vaccine after each immunization. To assess preliminary information of immunogenicity following Rotavirus (Bio Farma) vaccine immunization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Rotavirus (Bio Farma) Vaccine | Rotavirus (Bio Farma) Vaccine |
| OTHER | Placebo | Placebo contains 30% sucrose in DMEM |
Timeline
- Start date
- 2018-04-09
- Primary completion
- 2019-02-18
- Completion
- 2019-03-30
- First posted
- 2018-03-12
- Last updated
- 2019-04-03
Locations
4 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT03462108. Inclusion in this directory is not an endorsement.