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Sponsored by: |
Allergy Therapeutics |
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Information provided by: | Allergy Therapeutics |
ClinicalTrials.gov Identifier: | NCT00118612 |
Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to tree pollen (hay fever). The purpose of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and alder pollen.
Condition | Intervention | Phase |
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Type I Hypersensitivity |
Biological: Tree MATA MPL |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Double-Blind Phase IIb Study to Evaluate the Safety and Efficacy of Different Doses of Tyrosine Adsorbed Birch + Hazel + Alder Pollen Allergoid With MPL® in Patients Sensitized to Birch, Hazel, Alder Pollen |
Estimated Enrollment: | 68 |
Study Start Date: | July 2005 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Allied Research International Inc. | |
Mississauga, Ontario, Canada, L4W 1N2 |
Principal Investigator: | Deepen Patel, MD | Allied Research International Inc. |
Study ID Numbers: | TreeMATAMPL203, P2DP05003 |
Study First Received: | July 1, 2005 |
Last Updated: | January 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00118612 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Allergy Specific Immunotherapy Allergy Vaccination Allergenicity |
Monophosphoryl lipid A Hypersensitivity Immunologic Factors Adjuvants, Immunologic Hypersensitivity, Immediate |
Monophosphoryl lipid A Hypersensitivity Immunologic Factors Immune System Diseases |
Physiological Effects of Drugs Adjuvants, Immunologic Hypersensitivity, Immediate Pharmacologic Actions |