"A Clinical Study to Evaluate the Effectiveness of Beltavac® with polymerized extract of grass pollen mixture in allergic rhinoconjunctivitis in patients with allergic rhinoconjunctivitis associated or not with asthma"

You likely can't join if

• 1. Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion, 2. Previous immunotherapy with grass pollen allergens within the last 5 years, 3. Ongoing immunotherapy with grass pollen allergens or any other allergens, 4. Participants with acute allergic rhinitis/rhinoconjunctivitis due to other environmental allergens during the study period, 5. Participants with a sensitization to other environmental allergens (i.e., other pollens, house dust mites, cat dander, dog dander or other perennial antigens) when they present relevant symptoms that can interferes with grasses pollen season or the CPT performance, 6. Being in any relationship or dependence with the Sponsor, CRO and/or Investigator, 7. Inability to understand instructions/study documents, 8. Participants who do not have access to a smartphone/tablet (iOS or Android, in exceptional cases, a paper diary may be issued if installation on the mobile device is not technically possible), 9. History of severe systemic reactions and/or anaphylaxis, including to food (e.g., peanut, marine animals) or to Hymenoptera venom (e.g., bee, wasp stings) or to medication (e.g., penicillin), etc., 10. History of hypersensitivity to the excipients of the investigational product or placebo, 11. Mild persistent to severe persistent asthma partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2023, (26)) 12. Chronic asthma or emphysema,particularly with a forced expiratory volume in 1 second (FEV1) <80% of the participant’s reference value (ECSC) or Peak Expiratory Flow (PEF) <80% of the participants’ individual optimal value, 13. History of a respiratory tract infection and/or exacerbation of asthma within 2 weeks before the screening, 14. History of significant renal disease or chronic hepatic disease, 15. Malignant active disease (ongoing or within the five past years), 16. Severe autoimmune disease, 17. Immune defects including immunosuppression, immunopathies, 18. Vaccination during the entire treatment period, except flu and SARS-CoV-2 vaccinations, 19. Use of systemic immunosuppressive medications (e.g., methotrexate or cyclosporine A) or blood transfusion from one month before screening until the end of the trial,20. General inflammatory, severe acute or chronic inflammatory diseases, 21. Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc. 22. Intake of antidepressant drugs with potent antihistamine properties such as tricyclic antidepressants (e.g., doxepin, amitriptyline, desipramine, imipramine, etc.), 23. Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents, 24. Intake of beta-blockers, 25. Active tuberculosis, 26. Having any contraindication for the use of adrenaline (including hyperthyroidism), 27. Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus, 28. Females who are pregnant, lactating, or of child-bearing potential and not using a highly effective contraceptive method, 29. Administration of corticosteroids (systemic or nasal) or of anti-histaminic drugs before the screening visit (V0), as defined in the Table 6: Waiting period for screening; exception made for routine (previously prescribed) control medication for asthmatic participants,
• 30. Clinically relevant laboratory values, i.e., grade ≥2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit (Participants with laboratory values > grade 1 will require retesting. Upon normalization of the out-of-range value(s), participant will be eligible), 31. Participants for who the Investigator believes will not comply with the study protocol (participants with known alcohol or drug abuse or with a history of a serious psychiatric disorder as well as participants unwilling to give informed consent or to abide by the requirements of the protocol). 32. Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 33. Ocular disorders, such as inflammation/infection of the conjunctiva, cornea, or iris and in case of severe dry eye syndrome. 34. Any type of eye surgery in the last 6 months. 35. Ocular surface diseases in which IgE-mediated hypersensitivity is not involved: Sjögren’s syndrome, blepharitis, blepharoconjunctivitis, urban ocular allergy syndrome, dry eye syndrome, giant papillary conjunctivitis after intolerance to contact lenses or foreign bodies.