Safety assessments
SAEs, Toxicity
EVENTS
The safety and tolerability of PIV5-RSV intranasal vaccine were assessed over the period of 6 months after vaccination. Participants recorded the information of local and systemic AEs for 7 days after vaccination (solicited local and systematic events) and unsolicited AEs for 28 days using a memory aid. SAEs and AESIs were collected at scheduled study follow-up visits or unscheduled visits for the full duration of the study (6 months). AEs were graded according to the U.S. Food and Drug Administration Center for Biologics Evaluation and Research Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials guidelines. All unsolicited AEs were categorized by the investigator for possible causative association with vaccination (i.e., relatedness to vaccination).