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Sections: Correlations,
Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4140 | Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care. Wiki | 0.45 |
| drug260 | Alteplase 100 MG [Activase] Wiki | 0.45 |
| drug36 | 1: ILT101 Wiki | 0.45 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D018450 | Disease Progression NIH | 0.20 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.11 |
| D055371 | Acute Lung Injury NIH | 0.11 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 5 clinical trials
The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort, in healthy adults aged greater than or equal to 18 to less than or equal to 55 years and in adults aged greater than or equal to 65 years in good health with or without stable underlying conditions.
Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination Time: Day 8 (7 Days after first vaccination on Day 1)Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination Time: Day 64 (7 Days after second vaccination on Day 57)Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after first vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination Time: Day 8 (7 Days after first vaccination on Day 1)Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after second vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination Time: Day 64 (7 Days after second vaccination on Day 57)Description: Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination Time: Day 29 (28 Days after first vaccination on Day1)Description: Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination Time: Day 85 (28 Days after second vaccination)Description: SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Measure: Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the Second Vaccination Time: From Day 57 (vaccination 2) up to 1 yearDescription: SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Measure: Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination Time: Day 1 (vaccination 1) up to 6 MonthsDescription: Number of participants with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported.
Measure: Cohorts 1, 2, and 3: Number of Participants With SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) Time: Up to 38 MonthsDescription: Number of participants with SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.
Measure: Cohorts 1, 2, and 3: Number of Participants with SARS-CoV-2 Binding Antibodies Assessed by ELISA Time: Up to 38 MonthsDescription: Number of participants with Th-1 and Th-2 immune responses will be reported. Th1 and Th2 immune responses will be assessed by flow cytometry after SARS-CoV-2 S protein peptide stimulation of peripheral blood mononuclear cells (PBMCs) and intracellular staining [ICS] including cluster of differentiation (CD)-4+/CD-8+, Interferons (INF)-gamma, interleukin [IL] 2, Tumor Necrosis Factor (TNF)-alpha, IL-4, IL-5, IL-13, and/or other Th-1/Th-2 markers.
Measure: Cohorts 1, 2, and 3: Number of Participants with T-helper (Th)-1 and Th-2 Immune Responses as Assessed by Flow Cytometry Time: Up to 38 MonthsThe study will enroll up to 60,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.
Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus Time: 1 Day post-vaccination (Day 2) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease COVID-19 Regardless of Their Serostatus Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) Time: 1 Day post-vaccination (Day 2) to end of study (2.1 Years)Description: Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination will be reported.
Measure: Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: The viral load of SARS-CoV-2 will be assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs will be used to detect and/or quantify SARS-CoV-2.
Measure: SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Molecularly confirmed mild COVID-19 is defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Molecularly confirmed moderate and severe/critical COVID-19 defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of this protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized case Definition Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Measure: Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Serologic conversion between baseline and (Day 1; pre-vaccination), Day 71, 6 Months, 1 year post-vaccination using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported.
Measure: Serologic Conversion Between Baseline and (Day 1; Pre-vaccination), Day 71, 6 Months and 1- Year Post-vaccination using an Enzyme-linked Immunosorbent Assay (ELISA) Time: Between baseline (Day 1; pre-vaccination) and Day 71, 6 Months, 1-Year post-vaccination (up to 52 Weeks)Description: Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after vaccination (Day 15) to end of Study (2.1 Years) will be reported.
Measure: Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measure: Number of Participants with Serious Adverse Events (SAEs) Time: Up to 104 WeeksDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Time: Up to 6 MonthsDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Leading to Study Discontinuation Time: Up to 104 WeeksDescription: Participants will be asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Measure: Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination Time: Up to Day 8 (7 Days after first vaccination on Day 1)Description: Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Participants should record the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Measure: Number of Participants with Solicited Systemic AEs During 7 Days Following Vaccination Time: Up to Day 8 (7 Days after first vaccination on Day 1)Description: Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measure: Number of Participants with Unsolicited Local Adverse Events (AEs) During 28 Days Post-vaccination Time: Up to Day 29 (28 Days after first vaccination on Day 1)Description: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported
Measure: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) Time: Up to 104 WeeksDescription: SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.
Measure: SARS-CoV-2 Binding Antibodies Assessed by ELISA Time: Up to 104 WeeksThe purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) at 2-dose levels, as 2-dose schedule in healthy participants aged greater than or equal to 20 to less than or equal to 55 years and greater than or equal to 65 years in good health with or without stable underlying conditions.
Description: Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically questioned and which are noted by participants in their diary for 7 days post first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling and induration at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Number of Participants with Solicited Local Adverse Events (AEs) for 7 days after First Vaccination Time: Day 8 (7 days after first vaccination on Day 1)Description: Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically questioned and which are noted by participants in their diary for 7 days post second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling and induration at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Number of Participants with Solicited Local AEs for 7 days after Second Vaccination Time: Day 64 (7 days after second vaccination on Day 57)Description: Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.
Measure: Number of Participants with Solicited Systemic AEs for 7 days after First Vaccination Time: Day 8 (7 days after first vaccination on Day 1)Description: Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.
Measure: Number of Participants with Solicited Systemic AEs for 7 days after Second Vaccination Time: Day 64 (7 days after second vaccination on Day 57)Description: Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
Measure: Number of Participants with Unsolicited AEs for 28 days after First Vaccination Time: Day 29 (28 days after first vaccination on Day 1)Description: Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
Measure: Number of Participants with Unsolicited AEs for 28 days after Second Vaccination Time: Day 85 (28 days after second vaccination on Day 57)Description: SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Measure: Number of Participants with Serious Adverse Events (SAEs) Time: Up to 12 monthsDescription: SARS-CoV-2 neutralization will be measured by VNA to analyse the neutralizing antibodies to the wild-type virus and/or pseudovirion expressing S protein.
Measure: Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Neutralization as measured by Virus Neutralization Assay (VNA) Time: Up to 12 monthsDescription: SARS-CoV-2 binding antibodies will be measured by ELISA to analyse the antibodies binding to the SARS-CoV-2 S protein.
Measure: SARS-CoV-2-Binding Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) Time: Up to 12 monthsThe primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination; and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart).
Description: Serological response to vaccination as measured by VNA titers 28 days after Vaccination 2 will be reported.
Measure: Groups 1-6: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 days after Vaccination 2 Time: 28 days after Vaccination 2 (Day 85)Description: Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/mL [EU/mL]) 28 days after Vaccination 2 will be reported.
Measure: Groups 1-6: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 days after Vaccination 2 Time: 28 days after Vaccination 2 (Day 85)Description: The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.
Measure: Groups 1-6: Virus Neutralization Assay Geometric Mean Titer (GMT) 28 Days After Vaccination 2 Time: 28 Days after Vaccination 2 (Day 85)Description: The GMCs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.
Measure: Groups 1-6: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations (GMCs) 28 Days After Vaccination 2 Time: 28 Days after Vaccination 2 (Day 85)Description: Serological response to vaccination as measured by VNA titers 28 days after Vaccination 1 will be reported.
Measure: Groups 1-6: Serological Response to Vaccination as Measured by VNA Titers 28 days after Vaccination 1 Time: 28 Days after Vaccination 1 (Day 29)Description: Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 28 days after Vaccination 1 will be reported.
Measure: Groups 1-6: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay 28 days after Vaccination 1 Time: 28 Days after Vaccination 1 (Day 29)Description: The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.
Measure: Groups 1-6: Virus Neutralization Assay Geometric Mean Titer 28 Days After Vaccination 1 Time: 28 Days after Vaccination 1 (Day 29)Description: The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.
Measure: Groups 1-6: Enzyme-Linked Immunosorbent Assay Geometric Mean Concentrations 28 Days After Vaccination 1 Time: 28 Days after Vaccination 1 (Day 29)Description: Serological response to vaccination as measured by VNA titers 28 days after Vaccination 2 will be reported.
Measure: Groups 7-8: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 days after Vaccination 2 Time: 28 days after Vaccination 2 (Day 85)Description: Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 28 days after Vaccination 2 will be reported.
Measure: Groups 7-8: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay 28 days after Vaccination 2 Time: 28 days after Vaccination 2 (Day 57)Description: The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.
Measure: Groups 7-8: Virus Neutralization Assay GMTs 28 Days After Vaccination 2 Time: 28 Days after Vaccination 2 (Day 57)Description: The GMCs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.
Measure: Groups 7-8: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations 28 Days After Vaccination 2 Time: 28 Days after Vaccination 2 (Day 57)Description: Serological response to vaccination as measured by VNA titers 28 days after Vaccination 2 will be reported.
Measure: Groups 9-10: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 days after Vaccination 2 Time: 28 days after Vaccination 2 (Day 113)Description: Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 28 days after Vaccination 2 will be reported.
Measure: Groups 9-10: Serological Response to Vaccination as Measured by ELISA 28 days after Vaccination 2 Time: 28 days after Vaccination 2 (Day 113)Description: The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.
Measure: Groups 9-10: Virus Neutralization Assay GMT 28 Days After Vaccination 2 Time: 28 Days after Vaccination 2 (Day 113)Description: The GMCs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.
Measure: Groups 9-10: Enzyme-linked Immunosorbent Assay GMCs 28 Days After Vaccination 2 Time: 28 Days after Vaccination 2 (Day 113)Description: Solicited local AEs include (injection site pain/tenderness, erythema and swelling at the study vaccine injection site and the extent (largest diameter) of any erythema and swelling [using the ruler supplied]) will be noted in the participant diary after 7 days after each vaccination.
Measure: Groups 1-6: Number of Participants with Solicited Local AEs for 7 Days after Each Vaccination Time: 7 days after each vaccination (Up to 64 Days)Description: Solicited local AEs include (injection site pain/tenderness, erythema and swelling at the study vaccine injection site and the extent (largest diameter) of any erythema and swelling [using the ruler supplied]) will be noted in the participant diary after 7 days after each vaccination.
Measure: Groups 7-8: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Each Vaccination Time: 7 days after each vaccination (Up to 64 Days)Description: Solicited local AEs include (injection site pain/tenderness, erythema and swelling at the study vaccine injection site and the extent (largest diameter) of any erythema and swelling [using the ruler supplied]) will be noted in the participant diary after 7 days after each vaccination.
Measure: Groups 9-10: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Each Vaccination Time: 7 days after each vaccination (Up to 64 Days)Description: Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of each vaccination.
Measure: Groups 1-6: Number of Participants with Solicited Systemic AEs for 7 Days after Each Vaccination Time: 7 days after each vaccination (Up to 64 Days)Description: Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of each vaccination.
Measure: Groups 7-8: Number of Participants with Solicited Systemic AEs for 7 Days after Each Vaccination Time: 7 days after each vaccination (Up to 64 Days)Description: Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of each vaccination.
Measure: Groups 9-10: Number of Participants with Solicited Systemic AEs for 7 Days after Each Vaccination Time: 7 days after each vaccination (Up to 64 Days)Description: Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measure: Groups 1-6: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination Time: 28 days after each vaccination (Up to 85 Days)Description: Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measure: Groups 7-8: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination Time: 28 days after each vaccination (Up to 85 Days)Description: Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measure: Groups 1-10: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination Time: 28 days after each vaccination (Up to 85 Days)Description: SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measure: Groups 1-10: Number of Participants with Serious Adverse Events (SAEs) Time: Up to Day 450Description: Serological response to vaccination as measured by VNA titers 7 days after antigen presentation will be reported.
Measure: Groups 1-10: Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation Time: 7 days after antigen presentation (Day 176 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10])Description: Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 7 days after antigen presentation will be reported.
Measure: Groups 1-10: Serological Response to Vaccination as Measured by ELISA 7 Days After Antigen Presentation Time: 7 days after antigen presentation (Day 176 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10])Description: The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.
Measure: Groups 1-10: VNA GMT 7 Days After Antigen Presentation Time: 7 days after antigen presentation (Day 176 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10])Description: The GMCs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.
Measure: Groups 1-10: Enzyme-Linked Immunosorbent Assay Geometric Mean Concentrations 7 Days After Antigen Presentation Time: 7 days after antigen presentation (Day 176 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10])Description: Solicited local AEs (include injection site pain/tenderness, erythema and swelling at the study vaccine injection site and the extent [largest diameter] of any erythema and swelling [using the ruler supplied]) will be noted in the participant diary 7 days after antigen presentation.
Measure: Groups 1-10: Number of Participants with Solicited Local Adverse Events for 7 Days After Antigen Presentation Time: 7 days after antigen presentation (Day 176 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10])Description: Solicited systemic AEs include (body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary 7 days after antigen presentation.
Measure: Groups 1-10: Number of Participants with Solicited Systemic Adverse Events for 7 Days After Antigen Presentation Time: 7 days after vaccination (Up to Day 175 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10])Description: Number of participants with unsolicited AEs for 28 days after antigen presentation will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measure: Groups 1-10: Number of Participants with Unsolicited AEs for 28 Days After Antigen Presentation Time: 28 days after antigen presentation (Day 197 [Groups 1-6]; Day 169 [Groups 7-8]; Day 225 [Groups 9-10])Description: Number of participants with SAEs throughout the study (from antigen presentation until end of the study) will be reported. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measure: Groups 1-10: Number of Participants with Serious Adverse Events Throughout the Study Time: Up to Day 450Description: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported.
Measure: Groups 1-10: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by VNA Time: Up to Day 450Description: SARS-CoV-2 binding antibodies as assessed by ELISA to measure humoral immune response will be reported.
Measure: Groups 1-10: SARS-CoV-2 Binding Antibodies Measured as Assessed by ELISA Time: Up to Day 450The study will enroll up to 30,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in adult participants.
Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of signs and symptoms or severe COVID-19 defined in Food and Drug Administration (FDA) guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus Time: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus Time: 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline Time: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline Time: 14 days after the 1st vaccination (Day 15) to end of study (2 years and 3 months)Description: Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray, computed tomographic [CT] findings) linked to any molecularly confirmed COVID-19 at least 14 days after the second vaccination will be reported.
Measure: Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: The viral load of SARS-CoV-2 will be assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs will be used to detect and/or quantify SARS-CoV-2.
Measure: SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19 Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: Molecularly confirmed mild COVID-19 is defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19 Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: Molecularly confirmed moderate and severe/critical COVID-19 defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case definition at the time of finalization of this protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
Measure: Number of Participants with First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate, or severe/critical COVID-19 case.
Measure: Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: Serologic conversion between baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported.
Measure: Serologic Conversion Between Baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination Using an Enzyme-linked Immunosorbent Assay (ELISA) Time: Between baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccinationDescription: Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after second vaccination (Day 71) to end of Study (2.3 years) will be reported.
Measure: Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measure: Number of Participants with Serious Adverse Events (SAEs) Time: Up to 2 years and 3 monthsDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Time: 6 months after second vaccination (Up to 34 weeks)Description: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Leading to Study Discontinuation Time: Up to 2 years and 3 monthsDescription: Participants will be asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post each vaccination (day of each vaccination and the subsequent 7 days).
Measure: Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination Time: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57)Description: Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Participants should record the temperature in the e-Diary in the evening of the day of each vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post each vaccination (day of each vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Measure: Number of Participants with Solicited Systemic AEs During 7 Days Following Each Vaccination Time: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57)Description: Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measure: Number of Participants with Unsolicited Local Adverse Events (AEs) During 28 Days Post-vaccination Time: Up to Day 29 (28 days after first vaccination on Day 1), up to Day 85 (28 days after second vaccination on Day 57)Description: SARS-CoV-2 binding antibodies as assessed ELISA to measure humoral immune response will be reported.
Measure: SARS-CoV-2 Binding Antibodies Assessed by ELISA Time: Up to 2 years and 3 monthsDescription: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported
Measure: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) Time: Up to 2 years and 3 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports