Trial · NCT02485301
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Solicited Local Adverse Events | During the 7-Day (Days 0-6) post-vaccination period | Assessed solicited local adverse events were pain, redness and swelling. Any = occurrence of any solicited local adverse event regardless of their intensity grade. Grade 3 Pain = significant pain at rest. Prevented normal every day activities. Grade 3 Redness/Swelling = redness/swelling spreading beyond 100 millimeters (mm) from injection site. |
| Primary | Number of Subjects With Solicited General Adverse Events | During the 7-Day (Days 0-6) post-vaccination period | Assessed solicited general adverse events were fatigue, fever \[defined as axillary temperature higher than or equal to (≥) 37.5 degrees Celsius (°C)\], gastrointestinal (gastro) adverse events \[nausea, vomiting, diarrhoea and/or abdominal pain\] and headache. Any = occurrence of any general adverse events regardless of intensity grade or relationship to vaccination. Grade 3 fatigue, gastrointestinal symptoms and headache = adverse event that prevented normal activities. Grade 3 fever = fever ≥ 39.5 °C. Related = adverse event assessed by the investigator as related to the vaccination. |
| Primary | Number of Subjects With Unsolicited Adverse Events (AEs) | During the 30-Day (Days 0-29) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | At Screening | Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | At Day 3 | Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | At Day 6 | Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | At Day 30 | Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | At Month 6 | Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | At Month 6 + 6 Days | Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | At Month 6 + 30 Days | Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | At Month 12 | Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | At Screening | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | At Day 3 | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | At Day 6 | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | At Day 30 | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | At Month 6 | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | At Month 6 + 6 Days | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | At Month 6 + 30 Days | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | At Month 12 | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. |
| Primary | Number of Subjects With Adverse Events of Specific Interest (AESI) | During the 7-Day (Days 0-6) post-vaccination period | AESI included clinical symptoms of thrombocytopenia. |
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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