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

COVID-19 prophylaxis (children) meta-analysis

C4591001 (Adolescents 12-25)
  NCT04368728		 RCTComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (children)some concern
1134/1130 suggested
  • suggested 92 % decrease in confirmed Covid-19, from 1st dose with a moderate degree of certainty due to some concern in risk of bias
  • suggested 97 % decrease in symptomatic Covid-19 with a moderate degree of certainty due to some concern in risk of bias
Walter E.B. (Children <12 Years of Age)
  NCT04816643		 RCTComirnaty (tozinameran - Pfizer/BIONTECH)placeboCOVID-19 prophylaxis (children)NA
1528/757 conclusif
  • demonstrated 91 % decrease in confirmed COVID (any severity) (PE)
Lutrick (PROTECT study) OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (children)NA
-/- suggested
  • suggested 92 % decrease in confirmed COVID (any severity)
Klein ( VISION network) OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (children)NA
-/- suggested
  • suggested 92 % decrease in hospitalization
  • suggested 46 % decrease in symptomatic Covid-19
  • suggested 38 % decrease in symptomatic Covid-19
Glatman-Freedman A OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (children)NA
-/- suggested
  • suggested 91 % decrease in confirmed COVID (any severity),confirmed COVID (any severity)
June OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (children)NA
439079/863341 safety concern
  • suggested 91 % decrease in confirmed Covid-19, from 1st dose
  • suggested 99 % decrease in confirmed COVID (any severity)
  • statistically significant 98.1-fold increase in infection (PCR positive symptomatic or not)
  • statistically significant 90.1-fold increase in vaccine efficacy after dose 1 (and before dose 2)
Reis OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (children)NA
-/- suggested
  • suggested 90 % decrease in confirmed COVID (any severity),confirmed COVID (any severity)
  • suggested 93 % decrease in symptomatic Covid-19,symptomatic Covid-19
Olson (July to October) OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (children)NA
-/- suggested
  • suggested 95 % decrease in hospitalization
Price OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (children)NA
-/- suggested
  • suggested 83 % decrease in hospitalization
  • suggested 68 % decrease in hospitalization,hospitalization
Veneti OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (children)NA
-/- suggested
  • suggested 91 % decrease in confirmed COVID (any severity)
Olson (June to September) OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (children)NA
-/- suggested
  • suggested 91 % decrease in hospitalization,hospitalization
Tartof
  NCT04848584		 OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (children), COVID-19 prophylaxis (excluding children)NA
-/- suggested
  • suggested 73 % decrease in confirmed COVID (any severity)
  • suggested 91 % decrease in confirmed COVID (any severity)
  • suggested 90 % decrease in hospitalization

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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