There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. Previously, high cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) were compared with the marketed dose of 5100 SU and were found to have acceptable tolerability and safety. The purpose of this study is to evaluate the tolerability and safety of an even higher cumulative dose regimen of 35600 SU. of Grass MATA MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen, to enable selection of the best dose to take forward for further development.
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Number and frequency of adverse events (AEs)
Timeframe: 36 - 48 days
Number and frequency of adverse reaction complexes (ARCs)
Timeframe: 36 - 48 days
Frequency of premature discontinuation from treatment or study due to AEs.
Timeframe: 36 - 48 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Systolic blood pressure
Timeframe: 30 - 40 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Diastolic blood pressure
Timeframe: 30 - 40 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Pulse
Timeframe: 30 - 40 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Body temperature
Timeframe: 30 - 40 days
Changes in routine clinical laboratory values - Serum Chemistry
Timeframe: 36 - 48 days
Changes in routine clinical laboratory values - Hematology
Timeframe: 36 - 48 days
Changes in routine clinical laboratory values - Urinalysis
Timeframe: 36 - 48 days
Changes in peak expiratory flow rate (PEFR) before and after injections in asthmatic patients
Timeframe: 30 - 40 days