Healthy Volunteers Clinical Trial
Official title:
Evaluation of the Utility of an Environmental Exposure Chamber (EEC) for Assessing Efficacy of Specific Immunotherapy (SIT) in Pivotal Clinical Trials
The study will explore how allergy symptoms experienced during the grass pollen season
compare to symptoms experienced in the Environmental Exposure Chamber (EEC).
There are 2 treatments in this study. Both treatments are injected under the skin.
Allergovit® Grasses works by helping the body's immune system get used to grass-pollen before
the grass pollen season begins which may lead to decreased sensitivity and reduced allergy
symptoms during the grass season. Placebo treatment does not contain grass pollen mixture,
and is not expected to reduce allergic symptoms overtime.
This is a Phase II trial, with a one year observational/baseline phase followed by a one year double-blind placebo-controlled, randomized, treatment phase. Approx. 137 grass pollen-allergic subjects and 20 non-allergic subjects will be enrolled in the baseline phase of the study. The primary objective of the trial is to investigate the relationship between allergy symptoms experienced by subjects (allergic and non-allergic) upon exposure to grass pollen-allergen in the EEC and the allergy symptoms experienced by subjects during the grass pollen season. ;
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