Trial · NCT04546724
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Seroprotective CHIKV Antibody Level for Baseline Negative Subjects 28 Days Post-vaccination | on Day 29 after single vaccination | 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. |
| Secondary | CHIKV-specific Neutralizing Antibody Titers | Until Day 180 | CHIKV-specific Neutralizing Antibody Titers on Day 8, and Day 29 Postvaccination as Determined by μPRNT ( (Micro Plaque Reduction Neutralization Test) Assay |
| Secondary | Number of Participants With Seroprotective CHIKV Antibody Level | Until Day 180 | Seroprotection rate, based on a surrogate of protection agreed with FDA Seroprotective CHIKV Antibody Level Defined as μPRNT (Micro Plaque Reduction Neutralization Test) for Baseline Negative Subjects |
| Secondary | Number of Participants With Seroconversion | Until Day 180 | Seroconversion was defined as CHIKV-specific neutralizing antibody titer of ≥ 20 based on µPRNT (Micro Plaque Reduction Neutralization Test) for baseline negative subjects |
| Secondary | Fold "Change" of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline | until Day 180 | Fold Change of CHIKV-specific Neutralizing Antibody Titers Determined by μPRNT ( (Micro Plaque Reduction Neutralization Test) as compared to baseline |
| Secondary | Number of Participants Reaching an X-fold Change in CHICKV-specific Neutralizing Antibody Titer Compared to Baseline | until Day 180 | Number of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold change of CHIKV-specific Neutralizing Antibody Titers Determined by μPRNT ( (Micro Plaque Reduction Neutralization Test) as compared to baseline |
| Secondary | Unsolicited AEs | Until Day 29 | Number of Participants with Unsolicited Adverse Events |
| Secondary | Solicited Injection Site AEs | within 10 days post-vaccination | Number of Participants with solicited injection site reactions |
| Secondary | Solicited Systemic AEs | within 10 days post-vaccination | Number of Participants with solicited systemic reactions |
| Secondary | Adverse Events | until Day 180 | Number of Participants with any Adverse Events |
| Secondary | Related Adverse Events | until Day 180 | Number of Participants with any related Adverse Events |
| Secondary | Serious Adverse Event | until Day 180 | Number of Participants with any Serious Adverse Events |
| Secondary | Related Serious Adverse Event | until Day 180 | Number of Participants with any Related Serious Adverse Events |
| Secondary | Adverse Event of Special Interest | within 21 days post-vaccination | 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. |
| Secondary | Related Adverse Event of Special Interest | within 21 days post-vaccination | Number of Participants with any Related 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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