Comparison · NCT04546724-ab3973e8
VLA1553 vs Placebo: Adverse Event of Special Interest
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. VLA1553 vs Placebo: Adverse Event of Special Interest. Trial comparisons, record NCT04546724-ab3973e8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04546724-ab3973e8
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00324 | 0.00176 | 0.00596 | wilson | |
| Risk in group 2 | 0.000968 | 0.000171 | 0.00546 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00228 | -0.00246 | 0.00511 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.35 | 0.43 | 26.2 | log | |
| Odds ratio, group 1 over group 2 | 3.36 | 0.43 | 26.3 | log | |
| Number needed to treat, for one more participant with the outcome on VLA1553 than on Placebo | 439 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | VLA1553 | VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose | 10 | 3,082 | OG000 |
| Group 2 | Placebo | Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo | 1 | 1,033 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Adverse Event of Special Interest
- Description
Number of Participants with any Adverse Event of Special Interest~AESI Definition:~The following cluster of symptoms suggestive of CHIKV infection with or without remissions or exacerbations received particular consideration:~1. Fever (≥38.0°C \[100.4°F\] measured orally) and~2. Acute (poly)arthralgia/arthritis most frequently in the extremities (wrists, ankles, and phalanges, often symmetric), back pain and/or neurological symptoms (e.g. confusion, optic neuritis, meningoencephalitis, or polyneuropathy) and/or cardiac symptoms (e.g. myocarditis) or One or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus \[foot plant\] and edema of the face and extremities), polyadenopathies; and~3. Onset of symptoms 2 to 21 days after vaccination and~4. Duration of event ≥3 days.
- Time frame
- within 21 days post-vaccination
- Population
Source ClinicalTrials.gov
Trial
- Title
- Pivotal Study to Evaluate Safety and Immunogenicity of a Live-Attenuated Chikungunya Virus Vaccine Candidate in Adults
- NCT number
- NCT04546724
- Phases
- PHASE3
- Conditions
- Chikungunya Virus Infection
- Interventions
- VLA1553, Placebo
- Lead sponsor
- Valneva Austria GmbH
- Results first posted
- 2022-07-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04546724?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT04546724-ab3973e8