Trials / Completed
CompletedNCT02093273
Evaluation on Immunogenicity and Safety Profile of Trivalent OPV (tOPV Bio Farma)
Phase II, Randomized, Double Blind, Prospective Intervention Study to Evaluate the Immunogenicity and Safety Profile of tOPV (Bio Farma) With Different Batch Numbers in Indonesian Infants
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 1 Minute – 1 Day
- Healthy volunteers
- Accepted
Summary
The objective of this study is to compare the antibody response 30 days after two doses of t OPV
Detailed description
The trial design is phase II, randomized, double blind, prospective intervention study. The subject study are 240 healthy, full term, newborn infants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | tOPV pilot batch | the tOPV vaccine is given orally |
| BIOLOGICAL | tOPV commercial batch | tOPV vaccine is given orally |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2014-01-01
- Completion
- 2014-02-01
- First posted
- 2014-03-20
- Last updated
- 2014-03-20
Locations
4 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT02093273. Inclusion in this directory is not an endorsement.