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NCT03425149 · ClinicalTrials.gov registry record · Phase 1
Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults
A Phase 1 study of Zika Virus and Zika Virus Infection, sponsored by Valneva Austria.
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT03425149: Completed Phase 1 study of Zika Virus and Zika Virus Infection, sponsored by Valneva Austria.
NCT03425149 is a Phase 1 study of Zika Virus and Zika Virus Infection that has completed, run by Valneva Austria. The registered enrollment target is 67 participants, below the 420-participant average among 3 other Zika Virus trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03425149, a Phase 1 study of Zika Virus and Zika Virus Infection, has completed, sponsored by Valneva Austria.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
In this Phase 1 study, two target dose levels of VLA1601, a purified, inactivated, whole Zika virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide (alum) will be evaluated: 6 antigen units (AU) and 3 AU of inactivated ZIKV vaccine. Each dose will be administered intramuscularly (i.m.) in the deltoid muscle on Days 0 and 28. In addition, an accelerated 2-dose vaccination schedule on Days 0 and 7 will be assessed for both doses.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL VLA1601
Study Locations (1)
Tennessee
- New Orleans Center for Clinical Research - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2018-02-24 |
| Est. Completion | 2018-11-16 |
| Phase | Phase 1 |
What the finished NCT03425149 record still lists
NCT03425149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 420-participant average among 3 other Zika Virus trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Zika Virus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03425149 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT03425149 about?
NCT03425149 is a clinical study titled "Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults". In this Phase 1 study, two target dose levels of VLA1601, a purified, inactivated, whole Zika virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide (alum) will be evaluated: 6 antigen units (AU) and 3 AU of inactivated ZIKV vaccine. Each dose will be administered intramuscularly (i.m.) in th...
What is the current status of trial NCT03425149?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2018-02-24. Estimated completion is 2018-11-16.
What conditions does trial NCT03425149 study?
This clinical trial studies the following conditions: Zika Virus, Zika Virus Infection.
What interventions are being tested in trial NCT03425149?
The interventions under investigation include: Placebo (BIOLOGICAL), VLA1601 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03425149?
This trial is sponsored by Valneva Austria, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03425149 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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