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C4591031- first boost, 2021 NCT04955626

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.