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Sponsored by: |
Cytos Biotechnology AG |
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Information provided by: | Cytos Biotechnology AG |
ClinicalTrials.gov Identifier: | NCT00293904 |
The purpose of this study is to evaluate whether the use of a specific immunomodulatory principle (QbG10) together with conventional grass pollen allergen leads to a more rapid and more pronounced decrease of sensitivity against pollen than with the grass pollen allergen alone
Condition | Intervention | Phase |
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Hypersensitivity |
Biological: CYT005-AllQbG10 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (CYT005-AllQbG10) in Subjects With Seasonal Rhinoconjunctivitis Due to Grass-Pollen Allergy |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
No reproductive potential due to menopause (one year without menses, in case of doubts serum FSH will be determined and must be >40 U/mL), hysterectomy, bilateral oophorectomy, or tubal ligation. Patient agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional months after the last immunization (hormone-based, or intrauterine device, or double barrier contraception, i.e. condom + diaphragm, condom or diaphragm + spermicidal gel or foam)
Exclusion Criteria:
Study ID Numbers: | CYT005-AllQbG10 02 |
Study First Received: | February 17, 2006 |
Last Updated: | September 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00293904 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Allergy Grass Pollen Systemic Immunotherapy |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Diseases Rhinitis, Allergic, Seasonal |
Hypersensitivity, Immediate Rhinitis Respiratory Hypersensitivity |
Hypersensitivity Otorhinolaryngologic Diseases Immune System Diseases Respiratory Tract Diseases Rhinitis, Allergic, Seasonal |
Hypersensitivity, Immediate Rhinitis Nose Diseases Respiratory Hypersensitivity |