Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Dose-Regimen Study of the Efficacy and Safety of TOLAMBA™ in Ragweed-Allergic Rhinitis Adults
The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe and effective in reducing the symptoms of ragweed allergy.
Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy
is a therapeutic option for patients who have allergy symptoms that cannot be adequately
controlled by avoidance of the allergen or medication. It may also be appropriate for those
who cannot tolerate their medications due to side effects or have difficulties with
medication compliance. This study compares the safety and efficacy of two different dosing
regimens of TOLAMBA™ with placebo in reducing the symptoms of ragweed-allergic adults over
two consecutive ragweed pollen seasons.
Comparison(s): Subject-rated allergy symptoms of subjects treated with TOLAMBA™ dose-intense
regimen or TOLAMBA™ lower-dose regimen, compared with subjects treated with placebo.
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