Trial NCT04436276
Publication Stephenson K, JAMA, 2021
Primary outcome on the report: 1. Solicited adverse events (AEs), collected through a diary, were recorded for each vaccination from the time of vaccination until 7 days after vaccination. 2. All other unsolicited AEs and special reporting situations, whether serious or nonserious, were reported for each vaccination from the time of vaccination until 28 days after vaccination. Unsolicited AEs with the onset date outside the timeframe defined above (>28 days after previous study vaccination), which were ongoing on the day of the subsequent vaccination, were recorded as such. 3. All serious AEs and AEs leading to participant discontinuation (regardless of the causal relationship) were reported for all participants from the moment of first vaccination until completion of the participant’s last study-related procedure, which may include contact for safety follow-up.

Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.