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

COVID-19 prophylaxis (excluding children) meta-analysis

Novavax phase 2 South Africa (2019nCoV-501)
  NCT04533399		 RCTNuvaxovid (NVX-CoV2373) NovavaxplaceboCOVID-19 prophylaxis (excluding children)some concern
2199/2188 suggested
  • suggested 49 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
Novavax phase 3 UK (2019nCoV-302)
  NCT04583995		 RCTNuvaxovid (NVX-CoV2373) NovavaxplaceboCOVID-19 prophylaxis (excluding children)NA
-/- suggested
  • suggested 90 % decrease in symptomatic Covid-19 (PE)
Novavax PREVEND-19 phase 3 US (2019nCoV-301)
  NCT04611802		 RCTNuvaxovid (NVX-CoV2373) NovavaxplaceboCOVID-19 prophylaxis (excluding children)low
-/- suggested
  • suggested 90 % decrease in confirmed COVID (any severity) with a high degree of certainty due to low risk of bias
Keech
  NCT04368988		 RCTNuvaxovid (NVX-CoV2373) NovavaxplaceboCOVID-19 prophylaxis (excluding children)NA
108/23 inconclusive
    There were no AEs of special interest associated with COVID-19 as defined by regulatory criteria for conditions listed in Table S2.

    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).

     

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