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

COVID-19 prophylaxis (children) meta-analysis

kidCOVE (part 2)
  NCT04796896		 RCTSpikevax (Moderna mRNA-1273 COVID-19 vaccine)placeboCOVID-19 prophylaxis (children)NA
3005/997 suggested
  • suggested 74 % decrease in confirmed COVID (any severity)
  • suggested 88 % decrease in symptomatic Covid-19
press realease March 23,2022 : - interim analysis showed a robust neutralizing antibody response in both age groups (6 month -2 years and 2 years to 6 years) after a 25 µg two-dose primary series of mRNA-1273 along with a favorable safety profile.- Using the Phase 3 COVE study COVID-19 definition, vaccine efficacy in children 6 months to 2 years was 43.7% and vaccine efficacy was 37.5% in the 2 to under 6 years age group
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
teenCOVE (P203) (Adolescents 12-17Y)
  NCT04649151		 RCTSpikevax (Moderna mRNA-1273 COVID-19 vaccine)placeboCOVID-19 prophylaxis (children)some concern
2489/1243 suggested
  • suggested 93 % decrease in confirmed COVID (any severity) 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)
10 studies excluded by filtering options (0 RCT / 10 OBS)

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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