Name (Synonyms) | Correlation | |
---|---|---|
drug982 | Paracetamol Wiki | 0.71 |
drug301 | ChAdOx1 nCoV-19 boost Wiki | 0.71 |
drug300 | ChAdOx1 nCoV-19 + boost Wiki | 0.71 |
drug816 | MenACWY vaccine + boost Wiki | 0.71 |
drug814 | MenACWY Wiki | 0.71 |
drug815 | MenACWY vaccine Wiki | 0.71 |
drug302 | ChAdox1 n-CoV vaccine low dose Wiki | 0.71 |
drug1080 | Prone position Wiki | 0.50 |
Name (Synonyms) | Correlation |
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There are 2 clinical trials
A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM).
Description: Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases Time: 6 monthsDescription: Occurrence of serious adverse events (SAEs) throughout the study duration
Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs) Time: 6 monthsDescription: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms Time: 7 days following vaccinationDescription: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms Time: 7 days following vaccinationDescription: Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs) Time: 28 days following vaccinationDescription: Change from baseline for safety laboratory measures (haematology and biochemistry blood results)
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests Time: 6 monthsDescription: Occurrence of disease enhancement episodes
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes Time: 6 monthsDescription: Number of deaths associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 Time: 6 monthsDescription: Number of hospital admissions associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 Time: 6 monthsDescription: Number of intensive care unit admissions associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 Time: 6 monthsDescription: Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates Time: 6 monthsDescription: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays Time: 6 monthsDescription: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 Time: 6 monthsDescription: Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus
Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through Virus neutralising antibody assays Time: 6 monthsDescription: All safety, reactogenicity, immunogenicity and efficacy endpoints
Measure: To assess safety, reactogenicity, immunogenicity and efficacy endpoints, for participants receiving prophylactic paracetamol Time: 6 monthsA phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in healthy UK volunteers.
Description: Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19
Measure: Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older. Time: 6 monthsDescription: Occurrence of serious adverse events (SAEs) throughout the study duration.
Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults and children Time: 6 monthsDescription: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited local reactogenicity signs and symptoms for 7 days following Time: 7 days post vaccinationDescription: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following Time: 7 days post vaccinationDescription: Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of unsolicited adverse events (AEs) for 28 days following vaccination Time: 28 days post vaccinationDescription: Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results)
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 through standard blood tests (full blood count, liver and kidney function tests) Time: 6 monthsDescription: Occurrence of disease enhancement episodes
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes Time: 6 monthsDescription: Number of hospital admissions associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: hospital admissions Time: 6 monthsDescription: Number of intensive care unit (ICU) admissions associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 Time: 6 monthsDescription: Number of deaths associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: number of deaths Time: 6 monthsDescription: Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates Time: 6 monthsDescription: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification Time: 28 days post vaccinationDescription: Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination
Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion Time: 28 days post vaccinationDescription: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2 and 3 only) Time: 6 monthsDescription: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only): local reactogenicity Time: 7 days post vaccinationDescription: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following booster vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only): systemic reactogenicity Time: 7 days post vaccinationDescription: Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) Time: 28 days post vaccinationDescription: Frequency of participants with clinically significant changes from baseline from pre-booster for safety laboratory measures (haematology and biochemistry blood results)
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) through standard blood tests (full blood count, liver and kidney function tests) Time: 6 monthsDescription: Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination (seroconversion rates)
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) via seroconversion Time: 56 days post vaccinationDescription: Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) Time: 56 days post vaccinationDescription: Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus
Measure: Exploratory Immunology by virus neutralising antibody assays Time: 6 monthsDescription: Cell analysis by flow cytometry assays
Measure: Exploratory Immunology by flow cytometry Time: 6 monthsDescription: Functional antibody assays
Measure: Exploratory Immunology by functional antibody assays Time: 6 monthsDescription: Reported by weekly survey to collect information about cases amongst household contacts and friends, contact with the general public, infection control procedures
Measure: Measure exposure to COVID-19 Time: 6 months