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

COVID-19 prophylaxis (excluding children) meta-analysis

Reindl-Schwaighofer RCTJanssen AD26 vaccine (JNJ-78436735)Comirnaty (tozinameran - Pfizer/BIONTECH)COVID-19 prophylaxis (excluding children)NA
100/101 inconclusive
    Sadoff
          NCT04436276    		 RCTJanssen AD26 vaccine (JNJ-78436735)placeboCOVID-19 prophylaxis (excluding children)NA
    		-/- inconclusive
      Interim Results of a Phase 1–2a Trial : cohort 1 (healthy adults 18-55y) and 3 (>65y). Data that are reported here were collected after the administration of the second dose (either vaccine or placebo) in cohort 1a and after the first dose in cohort 3
      ENSEMBLE (COV3001) unpublished
              NCT04505722      		 RCTJanssen AD26 vaccine (JNJ-78436735)placeboCOVID-19 prophylaxis (excluding children)some concern
      		21895/21888 conclusif
      • suggested 81 % decrease in deaths with a moderate degree of certainty due to some concern in risk of bias
      • demonstrated 67 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
      • suggested 82 % decrease in hospitalization with a moderate degree of certainty due to some concern in risk of bias
      MixNMatch Study
              NCT04889209      		 OBSJanssen AD26 vaccine (JNJ-78436735)mRNA vaccineCOVID-19 prophylaxis (excluding children)NA
      		-/- inconclusive
        Botton (EPI-PHARE) OBSJanssen AD26 vaccine (JNJ-78436735)Comirnaty (tozinameran - Pfizer/BIONTECH)COVID-19 prophylaxis (excluding children)NA
        		-/- safety concern
        • statistically significant 5.7-fold increase in hospitalization
        EPIPHARE (Janssen) OBSJanssen AD26 vaccine (JNJ-78436735)controlCOVID-19 prophylaxis (excluding children)NA
        		-/- safety concern
        • statistically significant 75 % increase in Myocardial infarction
        Husby (janssen) OBSJanssen AD26 vaccine (JNJ-78436735)controlCOVID-19 prophylaxis (excluding children)NA
        		-/- inconclusive

          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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