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Study Ref. Design studied treatmentcontrol treatmentpatientsstudy risk of biassample sizes Results

COVID-19 prophylaxis (excluding children) meta-analysis

COVE Moderna/NIH phase 3 (study 301)
 
NCT04470427
RCTSpikevax (Moderna mRNA-1273 COVID-19 vaccine)placeboCOVID-19 prophylaxis (excluding children)some concern
15181/15170 conclusif
  • suggested 95 % decrease in confirmed Covid-19, from 1st dose with a moderate degree of certainty due to some concern in risk of bias
  • suggested 93 % decrease in vaccine efficacy from randomization (ITT) with a moderate degree of certainty due to some concern in risk of bias
  • demonstrated 94 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
  • demonstrated 98 % decrease in severe COVID-19 occurrence (PE) with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 14 % increase in adverse events with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 17.4-fold increase in arthralgia, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 41 % increase in hypersensitivity, all terms with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 2.5-fold increase in lymphadenopathy, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 26.6-fold increase in myalgia, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 42.3-fold increase in fever, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 32.7-fold increase in local adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 14.0-fold increase in local adverse reaction, grade 3-4, dose 2 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 5.7-fold increase in systemic adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 8.5-fold increase in systemic adverse reaction, grade 3-4, dose 2 with a moderate degree of certainty due to some concern in risk of bias
Moderna study 201 100µg
 
NCT04405076
RCTSpikevax (Moderna mRNA-1273 COVID-19 vaccine)placeboCOVID-19 prophylaxis (excluding children)NA
189/186 no results
    No deaths or unsolicited AEs that led to discontinuation from study vaccine or the study occurred within 28 days. One SAE of community-acquired pneumonia occurred on day 33 at 50 µg mRNA-1273 in the older cohort, resolved on day 58 and led to study vaccine discontinuation.
    Husby (Moderna) OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)NA
    -/- safety concern
    • suggested 59 % decrease in death D28
    • statistically significant 2.9-fold increase in myocarditis
    Klein OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)critical
    -/- suggested
      Southern California (Tseng) - delta OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)NA
      -/- suggested
      • suggested 95 % decrease in confirmed COVID (any severity)
      Southern California (Tseng) - omicron OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)NA
      -/- suggested
      • suggested 30 % decrease in confirmed COVID (any severity)
      Benotmane DESCSpikevax (Moderna mRNA-1273 COVID-19 vaccine)uncontrolled studyCOVID-19 prophylaxis (excluding children)NA
      -/- no results

        PE: primary endpoint; (a): to be demonstrated a result must be statistically significant on a primary endpoint (with multiplicity adjustment if necessary);
        Study risk of bias assessed for the study primary endpoint(s) or the main endpoints in case of no formally defined primary endpoint(s).