Trial · NCT07914244
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 | Incidence of Vaccination-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the day of vaccination up to Day 28 | Percentage of participants experiencing at least one vaccination-related adverse event (AE) or serious adverse event (SAE) graded by severity according to the toxicity scale |
| Primary | Frequency and Severity of Investigator-Observed Solicited Local and Systemic Adverse Reactions Within 7 Days Post-Vaccination | Day of vaccination (Day 1) and 6 subsequent days (Days 1-7) | Percentage of participants with investigator-confirmed solicited local (e.g., pain, redness, swelling at the injection site) and systemic (e.g., fever, headache, fatigue) reactions, classified by severity and relationship to the vaccine |
| Secondary | Frequency and Severity of Investigator-Observed Solicited Local and Systemic Adverse Reactions on Days 14 and 28 | Day 14 and Day 28 | Percentage of participants with investigator-confirmed solicited local and systemic reactions at scheduled follow-up visits |
| Secondary | Frequency and Severity of Participant-Reported Solicited Local and Systemic Adverse Reactions | From Day 8 to Day 27 post-vaccination (total of 21 days of observation) | Percentage of participants with self-reported solicited local and systemic reactions recorded in the Patient Diaries, evaluated by severity and relationship to the vaccine |
| Secondary | Change From Baseline in Systolic Blood Pressure | Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28 | Change in systolic blood pressure (mmHg) at each post-immunization clinic visit compared to the pre-immunization baseline measurement (Day 1) |
| Secondary | Change From Baseline in Diastolic Blood Pressure | Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28 | Change in diastolic blood pressure (mmHg) at each post-immunization clinic visit compared to the pre-immunization baseline measurement (Day 1) |
| Secondary | Change From Baseline in Heart Rate | Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28 | Change in heart rate (beats per minute) at each post-immunization clinic visit compared to the pre-immunization baseline measurement |
| Secondary | Change From Baseline in Body Temperature | Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28 | Change in body temperature (°C) at each post-immunization clinic visit compared to the pre-immunization baseline measurement |
| Secondary | Number of Participants With Clinically Significant Abnormal Physical Examination Findings | Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28 | Number of participants with new or worsened clinically significant abnormalities on physical examination relative to the pre-immunization baseline, as assessed by the investigator |
| Secondary | Change From Baseline in Hematology (Complete Blood Count) Parameters | Screening, Day 3, Day 14, Day 28 | Change from Screening in CBC parameters (hemoglobin, hematocrit, red blood cell count, white blood cell count with differential, platelet count) at Visit 3 (Day 3), Visit 8 (Day 14) and Visit 9 (Day 28). Parameters are reported individually in their standard units. |
| Secondary | Change From Baseline in Blood Biochemistry Parameters | Screening, Day 3, Day 14, Day 28 | Change from Screening in biochemistry parameters (e.g., ALT, AST, total bilirubin, creatinine, urea, glucose, total protein) at Day 3, Day 14 and Day 28. Parameters are reported individually in their standard units. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Urinalysis | Day 3, Day 14, Day 28 | Number of participants with clinically significant abnormal urinalysis findings (e.g., protein, glucose, blood, leukocytes), as assessed by the Investigator, at Day 3, Day 14 and Day 28 compared to Screening |
| Secondary | Change From Baseline in Total Immunoglobulin E (IgE) Level | Screening, Day 3, Day 14, Day 28 | Change from Screening in serum total IgE at Day 3, Day 14 and Day 28. Unit of Measure: IU/mL (or kU/L) |
| Secondary | Number of Participants With New or Worsened Abnormal Findings on Neurological Examination Compared With Screening | Screening, Visit 1 (Day 1), Visit 3 (Day 3), and Visit 9 (Day 28) | A standardized neurological examination is performed by the investigator using a structured form covering: level of consciousness, orientation, contact, and meningeal signs; cranial nerves I-XII; motor function (muscle tone, paresis, muscle strength in points, assessed separately on the right and left sides); reflexes (tendon, periosteal, plantar, pathological, oral automatism); superficial and deep sensation; coordination (gait, Romberg test, finger-to-nose and heel-to-shin tests, dysmetria, adiadochokinesis); pelvic functions; and higher mental functions (cognitive decline, aphasia). Findings are recorded as normal or abnormal. The outcome is the number of participants with at least one new or worsened abnormal finding compared with Screening. |
| Secondary | Change from Baseline in Electrocardiogram (ECG) Parameters | Screening and Visit 3 (Day 3) | Evaluation of changes in ECG parameters (including heart rate, PR, QRS, QT, and QTc intervals) and the emergence of new clinically significant abnormalities compared to the Screening baseline |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07914244/registered