Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
4–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Is between the ages of 4 and 17 years (inclusive) at enrollment in this study and is at least 5 years old at randomization
Has a clinical history of significant ragweed pollen-induced allergic rhinitis/rhinoconjunctivitis of ≥1 year (at least 1 season for ages 4 to 6 years) or ≥2 years (at least 2 seasons for ages 7 to 17 years) duration diagnosed by a physician (with or without asthma) and have received treatment for the condition during the previous ragweed season
If female, agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study.
You may not be if
Has a clinical history of symptomatic seasonal allergic rhinitis (and/or asthma) due to another allergen, which has required regular medication during, or potentially overlapping, the ragweed season
Has a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the subject is regularly exposed during the ragweed season which would interfere with assessment of the treatment effect
Has any nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis).
Has asthma requiring high daily doses of inhaled corticosteroids within the 6 months prior to the Screening visit
Is either \>7 years old and cannot perform reproducible FEV1 maneuvers despite coaching; OR is ≤7 years old and cannot perform reproducible FEV1 maneuvers despite coaching and has current symptoms of asthma characterized by recurrent episodes of wheezing, or episodes of cough, wheeze, difficulty in breathing, or chest tightness
Has severe, unstable, or uncontrolled asthma, as judged by the clinical investigator, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists) at any time within the last 3 months prior to the Screening or Randomization visits
Has a history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause, or inhalant allergen
Has a diagnosis of eosinophilic esophagitis
Has a history of chronic urticaria and/or chronic angioedema
Has a clinical history of chronic sinusitis during the 2 years prior to the Screening or Randomization visits
Has current severe atopic dermatitis
Has a history of allergy, hypersensitivity, or intolerance to the ingredients of the study drug (except for Ambrosia artemisiifolia), rescue medications, or self-injectable epinephrine
Has previously received short ragweed pollen allergen extract
Has previously been randomized into this study
Is participating in any other clinical study or plans to participate in another clinical study during the duration of this study
Clareo Health | Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)
