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Comirnaty - first boost (n=5081) vs. Comirnaty (tozinameran - Pfizer/BIONTECH) (n=5044)
randomized controlled trial
BNT162b2 vaccine
third dose
placebo
participants had previously received 2 doses of Comirnaty
COVID-19 prophylaxis (excluding children)
single-blind
123 sites in the United States, South Africa, and Brazil
During the interim analysis, the data monitoring committee recommended that participants be made aware of their trial-group assignments to allow those in the placebo group to receive a third vaccine dose. Data from participants who were made aware of trial-group assignments before the first interim analysis because of the regulatory decision were censored at the time of the unblinding of the trial group.
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