Summary of local and systemic reactogenicity and AEs.
nausea/vomiting, myalgia, fatigue, fever, headache, chills
ADVERSE EVENT
Grading scale: Grade 1 = mild (awareness of a symptom but the symptom is easily tolerated); grade 2 = moderate (discomfort enough to cause interference with usual activity); grade 3 = severe (incapacitating; unable to perform usual activities; requires absenteeism from work or bed rest). AE, adverse event.In group 1, all solicited systemic AEs reported by 5 of 15 participants were mild in intensity and included fatigue, headache, and myalgia being reported by 5 of 15, 2 of 15, and 1 of 15 participants, respectively. In group 2, the solicited systemic AEs reported by 8 of 15 participants were mild or moderate in intensity and included fatigue, headache, and myalgia being reported by 2 of 15, 5 of 15, and 5 of 15 participants, respectively, as well as chills, nausea/vomiting, and breathing discomfort being reported by 1 of 15 for each symptom. The single episode of breathing discomfort was mild and resolved within 2 days after vaccination. No solicited fever was reported in either group. Throughout the 6-month study period, five medically attended AEs were reported by four participants (all in group 2), none of which was assessed as being related to study vaccine.