Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)

Inclusion Criteria

• Participants must be 18 to 65 years of age, of either sex, and of any race.
• Participants must have a clinical history of significant allergic rhinoconjunctivitis to grass (with or without asthma) diagnosed by a physician and have received treatment for their disease during the previous GPS.
• Participants must have a positive skin prick test response (average wheal diameter >=5 mm larger than the saline control after 15 to 20 minutes) to Phleum pratense at the Screening Visit.
• Participants must be positive for specific IgE against Phleum pratense (>=IgE Class 2) at the Screening Visit.
• Participants must have an FEV1 >=70% of predicted value at the Screening Visit.
• Participants' safety laboratory tests, vital signs and ECG conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor.
• Participant must be willing to give written informed consent and be able to adhere to dose and visit schedules.
• Female participants of childbearing potential must be using a medically acceptable and adequate form of birth control. These include:
• hormonal contraceptives as prescribed by a physician (oral, hormonal vaginal ring, hormonal implant or depot injectable);
• medically prescribed intra-uterine device;
• medically prescribed topically-applied transdermal contraceptive patch;
• double-barrier method (eg, condom in combination with a spermicide); vasectomy and tubal ligation should each be considered as single barrier.
• Female participants of childbearing potential should be counseled in the appropriate use of birth control while in the study. Female participants who are not currently sexually active must agree and consent to use one of the above-mentioned methods if they become sexually active while participating in the study.
• Female participants of childbearing potential must have a negative urine pregnancy test at the Screening Visit in order to be considered eligible for enrollment.

Exclusion Criteria

• Participants with a clinical history of symptomatic seasonal allergic rhinitis and/or asthma, having received regular medications due to another allergen during or potentially overlapping the GPS.
• Participants with a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the subject is regularly exposed.
• Participants with sufficient pre-seasonal data in the observational phase will not be eligible to continue in the treatment phase if the subject: 1) does not experience an increase in rhinoconjunctivitis symptom score of equal to or greater than 4 above the pre-seasonal average symptom score for at least 2 days, 2) does not use allergy rescue medication for at least 2 days, during the observational phase Year 1 2008 GPS.
• Participants that received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
• Participants with a clinical history of severe asthma.
• Participants with history of anaphylaxis with cardiorespiratory symptoms.
• Participants with a history of self-injectable epinephrine use.
• Participants with a history of chronic urticaria and angioedema.
• Participants with clinical history of chronic sinusitis during the 2 years prior to the Screening Visit.
• Participants with current severe atopic dermatitis.
• Female participants who are breast-feeding, pregnant, or intending to become pregnant.
• Participatns who have had previous treatment by immunotherapy with grass pollen allergen or any other allergen within the 5 years prior to the Screening Visit.
• Participants with a known history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (except for Phleum pratense), rescue medications, or self-injectable epinephrine.
• Participants with any clinically significant condition or situation, other than the condi