Comparison of the efficacy and the safety of different schedules of administration of sub-lingual immunotherapy in patients with ragweed pollinosis: a phase III randomized and controlled clinical study.

INTERVENTION: Product Name: Ragweed estract Pharmaceutical Form: Oral drops INN or Proposed INN: AMBROSIA ARTEMISIIFOLIA L. Concentration unit: SU Standardised Unit(s) (Deprecated) Concentration type: equal Concentration number: 200‐ CONDITION: Subjects who are allergic to Ragweed. ; MedDRA version: 14.0 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 ‐ Immune system disorders Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: Evaluate the percentage of CD14‐PDL‐1‐IL10 + circulating allergen‐specific ragweed‐allergic patients undergoing pre‐seasonal regimen of SLIT administered sublingually vs oral‐vestibular;; Assess the percentage of CD14‐PDL‐1‐IL10 + circulating allergen‐specific ragweed‐allergic patients undergoing pre‐seasonal regimen of SLIT administered sublingually at a dose doubled 400 STU/dose vaccine compared to the commonly used marketing 200 STU/dose. Primary end point(s): The end of the study will detect a difference between groups with respect to the primary objective, the percentage of CD14‐PDL‐1‐IL10 + outstanding of at least 25 percentile points. Secondary Objective: Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine by vestibular compared to those treated sublingually;; Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose;; Evaluation of the safety and tolerability (as assessed by data collection form of local and systemic adverse events) among patients treated with sublingual vaccine in oral/vestibular administration compared to those treated sublingually;; Assessment of safety and tolerability (assessed using data forms of local and systemic adverse events) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose. Timepoint(s) of evaluation of this end point: At study termination (3 months). SECONDARY OUTCOME: Secondary end point(s): None. Timepoint(s) of evaluation of this end point: Not applicable. INCLUSION CRITERIA: Adults aged 18‐55 years, known allergy to ragweed pollen, no immunotherapy or in progress prior to enrollement, symptoms of rhino/conjunctivitis with or without asthma. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range