Safety assessment
ADVERSE EVENTS, ADVERSE EVENT, EVENTS
Results from physical examination, including vital signs and body temperature, pulse, and blood pressure was recorded at each time-point for vaccination. Adverse events (AEs) following vaccinations were self-reported by the study participants at each study visit. Briefly, upon each 30 min visit (up to 10 visits per study subject pending vaccination group), study participants described all events during the period since last visit to the responsible study nurse. Information was registered by the study nurse, and then AEs were graded by the responsible physician at the Karolinska Clinical Trial Alliance unit classifying them as mild, moderate, or severe, and ultimately recorded in the eCRF. This followed a pre-set, standard procedure used for clinical trials at this unit. Severe adverse events were, when so deemed, further classified, and reported as serious adverse events (SAEs). AEs and SAEs recorded for all study participants were deemed unlikely, possible, or probably related to the vaccinations.