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Safety-Reactogenicity
Local reaction: B1 (10-30ug)
• 18-55: mild to moderate pain at the injection site; more frequent post-dose-2 within 7 days
• 65-85: 92% reporting mild to moderate pain post-dose-1, and 75% post-dose-2.
Local reaction: B2 (10-30ug)
• Similar pattern observed
• 65-85: no swelling/redness observed
Systemic events: B1 (10-30ug)
• 18-55: mild to moderate fever and chills post dose 1; 75% reporting fever post dose 2 of 30ug
• 65-85: overall milder reaction; fatigue and headache post-dose-1 or 2; 33% reporting fever post-dose-2
• Overall dose-dependent; greater post-dose-2
Systemic events: B2 (10-30ug)
• 18-55: 17% reporting mild to moderate fever; small numbers reporting severe systemic events (fatigue, headache, chills, muscle pain, and joint pain)
• 65-85: 8% reporting mild to moderate fever; no severe events observed
• Overall milder than B1; 65-85 reporting systemic events similar to placebo group
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