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NCT04546724 · ClinicalTrials.gov registry record · Phase 3
Pivotal Study to Evaluate Safety and Immunogenicity of a Live-Attenuated Chikungunya Virus Vaccine Candidate in Adults
A Phase 3 study, sponsored by Valneva Austria.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,128
- Enrollment target
NCT04546724: Completed Phase 3 study, sponsored by Valneva Austria.
NCT04546724 is a Phase 3 study that has completed, run by Valneva Austria. The registered enrollment target is 4,128 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (435% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04546724, a Phase 3 study, has completed, sponsored by Valneva Austria.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,128 participants
- Enrollment target
Study Summary
This was a prospective, randomized, double-blinded, multicenter, pivotal clinical study evaluating the final dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo control. The final dose of VLA1553 or control was administered as single immunization on Day 1. Overall, 4.128 male and female subjects aged 18 years and above were randomized into the study.
Primary Outcome
Seroprotection rate, based on a surrogate of protection agreed with FDA Assay used for analysis was based on µPRNT (Micro Plaque Reduction Neutralization Test). Participants at pre-selected sites were included, if they had available Day 1 and Day 29 samples and without major protocol deviations that could impact the immune response.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL VLA1553
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,128 participants |
| Start Date | 2020-09-17 |
| Est. Completion | 2021-10-15 |
| Phase | Phase 3 |
What the finished NCT04546724 record still lists
NCT04546724 is an interventional study that assigns participants to a tested intervention. Its 4,128 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (435% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04546724 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04546724 about?
NCT04546724 is a clinical study titled "Pivotal Study to Evaluate Safety and Immunogenicity of a Live-Attenuated Chikungunya Virus Vaccine Candidate in Adults". This was a prospective, randomized, double-blinded, multicenter, pivotal clinical study evaluating the final dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo control. The final dose of VLA1553 or control was administered as single immunization on Day 1. Overall, 4.128 male and fe...
What is the current status of trial NCT04546724?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,128 participants. The study started on 2020-09-17. Estimated completion is 2021-10-15.
What interventions are being tested in trial NCT04546724?
The interventions under investigation include: Placebo (BIOLOGICAL), VLA1553 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04546724?
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 NCT04546724's enrollment target sits among peer trials
4,128 61st of 2000 higher than 1,940 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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