Comirnaty (tozinameran - Pfizer/BIONTECH) (n=1134) vs. placebo (n=1130)
randomized controlled trial
some concerns about risk of bias
BNT162b2
Two intramuscular injections of 30 μg of BNT162b2 21 days apart.
placebo
Two intramuscular injections of 30 μg of placebo (saline) 21 days apart.
COVID-19 prophylaxis (children)
double-blind
multinational
Walter E.B. (Children <12 Years of Age), 2021 NCT04816643
Comirnaty (tozinameran - Pfizer/BIONTECH) (n=1528) vs. placebo (n=757)
randomized controlled trial
risk of bias NA
BNT162b2 vaccine (2 doses)
Intramuscular (deltoid) injection of two doses of BNT162b2 administered 21 days apart at the dose level selected during phase 1 (10μg).
Placebo (2 doses)
Intramuscular (deltoid) injection of two doses of saline placebo administered 21 days apart.
COVID-19 prophylaxis (children)
Children with no or stable preexisting conditions were eligible to participate, except those with an immunocompromising or immunodeficiency disorder, those with a history of MIS-C, or those receiving immunosuppressive therapy (including cytotoxic agents and systemic glucocorticoids).
Double-blind.
81 sites in the United States, Spain, Finland, and Poland.