Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04838444 | Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553) | PHASE3 | ACTIVE NOT_RECRUITING | 363 | — | — | Apr 2, 2021 | May 1, 2031 | Dec 24, 2025 | 10 | United States |
| NCT04546724 | Pivotal Study to Evaluate Safety and Immunogenicity of a Live-Attenuated Chikungunya Virus Vaccine Candidate in Adults | PHASE3 | COMPLETED | 4,128 | — | — | Sep 17, 2020 | Oct 15, 2021 | Jun 28, 2023 | 44 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| VLA1553 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo |
| Name | Type | Description |
|---|---|---|
| VLA1553 | BIOLOGICAL | Trial participants previously vaccinated with VLA1553 in trial VLA1553-301 will be followed up for safety and immunogenicity. |
| Placebo | BIOLOGICAL | Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo |
Inclusion Criteria: * Individual participated in the VLA1553-301 clinical trial; * Participant has an understanding of the trial and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any trial-related procedures; * Participant had immunogenicity blood...