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    Moderna

    This report considers only clinical trials that are associated with COVID-19 vaccines.

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (5)


    Name (Synonyms) Correlation
    drug3923 mRNA-1273 Wiki 0.67
    drug457 Biological: mRNA-1273: 50 mcg Wiki 0.58
    drug1325 Flu shot Wiki 0.58
    Name (Synonyms) Correlation
    drug456 Biological: mRNA-1273: 100 mcg Wiki 0.58
    drug2490 Placebo Wiki 0.22

    Correlated MeSH Terms (2)


    Name (Synonyms) Correlation
    D045169 Severe Acute Respiratory Syndrome NIH 0.12
    D018352 Coronavirus Infections NIH 0.09

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There are 3 clinical trials


    1 A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older

    The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.

    NCT04470427
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: mRNA-1273
    2. Biological: Placebo

    Primary Outcomes

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of mRNA-1273

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Measure: Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal

    Time: Up to Day 759 (2 years after second dose)

    Measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

    Time: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose)

    Measure: Number of Participants with Unsolicited AEs

    Time: Up to Day 57 (28 days after each dose)

    Secondary Outcomes

    Description: Clinical signs indicative of severe COVID-19 as predefined for the study.

    Measure: Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of mRNA-1273

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 Infection as predefined for the study.

    Measure: Number of Participants with a First Occurrence of Either COVID-19 or SARS-CoV-2 Infection regardless of symptomatology or Severity Starting 14 Days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)]

    Description: Clinical signs indicative of secondary case definition of COVID-19 as predefined for the study.

    Measure: Number of Participants with a Secondary Case Definition of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 as predefined for the study.

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of mRNA-1273 or Placebo

    Time: Day 1 (first dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo regardless of evidence of prior SARS-CoV-2 Infection

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.

    Measure: Number of Participants with a First Occurrence of SARS-CoV-2 Infection in the Absence of Symptoms Defining COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Measure: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

    Measure: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

    Measure: Quantified Levels or GMT of S Protein-Specific Binding Antibody (bAb)

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

    Measure: GMFR of S Protein Specific bAb

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759
    2 A Phase 2/3, Randomized, Observer-Blind, Placebo Controlled Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS CoV 2 Vaccine in Healthy Adolescents 12 to <18 Years of Age

    The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety and reactogenicity of a single dose level of mRNA-1273 vaccine administered in 2 doses 28 days apart to an adolescent population.

    NCT04649151
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: mRNA-1273
    2. Biological: Placebo

    Primary Outcomes

    Measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

    Time: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose)

    Measure: Number of Participants with Unsolicited Adverse Events (AEs)

    Time: Up to Day 57 (28 days after each dose)

    Measure: Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI)

    Time: Up to Day 394 (1 year after second dose)

    Description: Acceptable serum Ab threshold as predefined for the study.

    Measure: Number of Participants Who have Reached the Acceptable Threshold for the Serum Ab Level at Day 57

    Time: Day 57 (28 days after second dose)

    Measure: Comparison of the Geometric Mean of the Serum Neutralizing Antibody (nAb) level against the Geometric Mean of the Serum nAb level in Study mRNA-1273-P301 (NCT04470427)

    Time: Day 57 (28 days after second dose)

    Secondary Outcomes

    Measure: Geometric Mean Value of SARS-CoV-2 Spike Protein (S2P)-specific binding antibody (bAb)

    Time: Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2)

    Measure: Geometric Mean Value of SARS-CoV-2-specific nAb

    Time: Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2)

    Description: Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.

    Measure: Number of Participants with a SARS-CoV-2 Infection Starting on Day 57

    Time: Day 57 up to Day 394

    Description: Clinical signs indicative of COVID-19 as predefined for the study.

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 394 (1 year after second dose)
    3 A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older

    This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 SARS-COV-2 vaccine in adults 18 years of age or older.

    NCT04405076
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: Biological: mRNA-1273: 50 mcg
    2. Other: Placebo
    3. Biological: Biological: mRNA-1273: 100 mcg

    Primary Outcomes

    Measure: Solicited local and systemic adverse reactions (ARs)

    Time: 7 days post-vaccination

    Measure: Unsolicited adverse events (AEs)

    Time: 28 days post-vaccination

    Measure: Medically-attended adverse events (MAAEs)

    Time: Month 0 through Month 13

    Measure: Serious adverse events (SAEs)

    Time: Month 0 through Month 13

    Measure: Change in the measure of clinical safety laboratory values in Cohort 2 from baseline

    Time: Through 1 month after last vaccination

    Measure: The number and percentage of participants with abnormalities in blood pressure, temperature, HR or respiratory rate will be assessed.

    Time: Through 1 year after last vaccination

    Measure: The number and percentage of participants with abnormalities in physical examinations will be assessed

    Time: Through 1 year after last vaccination

    Measure: Evaluate immunogenicity of mRNA-1273 by titer of SARS-CoV-2-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA)

    Time: Through 1 year after the final dose

    Secondary Outcomes

    Measure: Titer of SARS-CoV-2-specific neutralizing antibody (nAb)

    Time: Through 1 year post last vaccination

    Description: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer either from below the limit of detection (LOD) or lower limit of quantification (LLOQ) to equal to or above LOD or LLOQ, or a 4-times higher titer in participants with pre-existing nAb titers.

    Measure: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer

    Time: Through 1 year post last vaccination

    No related HPO nodes (Using clinical trials)


    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    No related HPO nodes (Using clinical trials)


    Reports

    Data processed on January 01, 2021.

    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.

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    MeSH

    706 reports on MeSH terms

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    306 reports on HPO terms

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    Alphabetical index of all Terms

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