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NCT01047839 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
A Phase 3 study, sponsored by Valneva Austria.
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT01047839: Completed Phase 3 study, sponsored by Valneva Austria.
NCT01047839 is a Phase 3 study that has completed, run by Valneva Austria. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01047839, a Phase 3 study, has completed, sponsored by Valneva Austria.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic
Primary Outcome
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
Interventions
- BIOLOGICAL IC51
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
What the finished NCT01047839 record still lists
NCT01047839 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which IC51 is the first listed.
NCT01047839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01047839 about?
NCT01047839 is a clinical study titled "Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries". The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic
What is the current status of trial NCT01047839?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2010-01. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01047839?
The interventions under investigation include: IC51 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01047839?
This trial is sponsored by Valneva Austria, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01047839's enrollment target sits among peer trials
100 1681st of 2000 higher than 288 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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