Solicited AEs.
irritability/fussiness, swelling, fever, allergic reaction, fatigue, myalgias, erythema, drowsiness, arthralgias, rash, pain, urticaria, pruritus, bruising, headache, tenderness, chills
ALLERGIC REACTION, ADVERSE EVENTS, ERYTHEMA, URTICARIA, INDURATION, ADVERSE EVENT
When all age groups were combined, solicited local AEs were observed with 12 of 225 doses of PfSPZ Vaccine (5.3%) compared with 2 of 69 doses of NS (2.9%; Solicited adverse events per vaccine dose, by groupAE = adverse event; PfSPZ = Solicited local AEs included pain, tenderness, pruritus, erythema, induration, swelling, and bruising.Solicited systemic AEs included fever, subjective fever, and allergic reaction (defined as urticaria or a rash, swelling, or pruritus distant from the site of injection) for all participants. Additional observations in participants aged 6 years and older included headache, myalgias, arthralgias, fatigue, malaise, and chills. In participants < 5 years old, solicited systemic AEs included drowsiness, irritability/fussiness, or inability or refusal to eat or drink.Maximum observed temperature in any participant was 38.5°C.The most frequent solicited systemic AE was headache, associated with 17 of 156 PfSPZ Vaccine doses in 15/56 participants aged 6–61 years (26.7%) compared with 2 of 51 NS doses in 1/17 participants (5.9%), a difference that was not significant (One participant, a 7-year-old girl, developed mild (grade 1) generalized pruritus without a visible rash 4 days after her first dose of 1.8 × 10Two grade 3 (severe) systemic solicited AEs were reported. A 15-year-old female experienced headache starting 1 day after her second immunization with 1.8 × 10