A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic injections of 2 different dose levels of the investigational short and tall ragweed product. Biomarkers will be assessed at baseline and at multiple time points post-treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
Short and Tall Ragweed Mix
Short and Tall Ragweed Mix
Saline with 0.4% Phenol
Andover Eye Associates
Andover, Massachusetts, United States
Adverse events (reported, elicited and observed)
Time frame: 47 weeks
Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale
Time frame: 47 weeks
Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale
Time frame: 47 weeks
Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale
Time frame: 47 weeks
Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale
Time frame: 47 weeks
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