Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)
Brief Summary: The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.


Options:
A: Inclusion Criteria:

1. Male or female outpatients aged 16 to 50 years (inclusive).
2. House dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year.
3. Sensitised to D. pteronyssinus and D.farinae (positive skin prick test (SPT) with wheal diameter ≥ 4 mm and specific IgE level ≥ 0.70 kU/L
4. Patients treated with inhaled corticosteroids (ICS) before the screening visit at a dose ≥ 200 µg and \< 1,000 µg equivalent budesonide/day.

Exclusion Criteria:

1. Mild intermittent asthma needed to be treated only with β2-agonist (GINA level 1).
2. Severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide.
3. FEV1 \< 70% of predicted value at Visit 1.
4. Co-sensitisation to other inhalant allergens than dust mites leading to clinically relevant allergic asthma and proven by a positive skin prick test with wheal diameter ≥ 4 mm and serum specific IgE ≥ 0.70 KU/L .
5. Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of the study. These diseases include, but are not limited to, past or current cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
B: Inclusion Criteria:

* Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the previous 2 pollen seasons requiring intake of symptomatic treatment.
* Sensitization to birch pollen demonstrated by a positive Skin Prick Test to birch pollen with wheal diameter \> 3 mm and birch pollen allergens specific IgE levels ≥ 0.70 kU/L.
* RRTSS based on the previous or on the penultimate birch pollen season ≥ 12 out of a maximum possible score of 18.
* Patients with an FEV1 (Forced Expiratory Volume at one second) ≥ 80% of the predicted value.
* Patients who are willing to comply with the protocol.
* Patients having given a signed informed consent before completing any study related procedure.

Exclusion Criteria:

* Patients with symptoms of rhinitis/rhinoconjunctivitis during the birch pollen season due to any other allergens (except alder and hazel). This includes patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study.
* Patient who previously received desensitization treatment to birch pollen and/or another Betulaceae sp. (for example hazel or alder) within the previous 5 years.
* Patients with ongoing treatment by immunotherapy with another allergen.
* Pregnancy (positive pregnancy test), breast-feeding.
* Female patients of childbearing potential planning a pregnancy during this study or not using a medically accepted contraceptive method (hormonal birth control \[orally, injectable or by implant, for at least 2 months before enrolment\], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner).
* Patients planning to move during the study or planning to leave the area during the birch pollen season for more than 1 week (7 consecutive days).
* Patients with moderate or severe persistent asthma (GINA 3 or 4).
* Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents.
* Patients with any nasal or oral condition that could interfere with the efficacy or safety assessments (such as nasal polyposis or oral inflammation).
* Patients with severe immune deficiency.
* Patients with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or outcome of this study.
* Any other disease or condition which would place a patient at undue risk by being included in the study (according to the Investigator's opinion).
* Usual contra-indications of immunotherapy such as concomitant beta-blocker therapy whatever the route and/or immunosuppressive drugs.
* Patients treated with inhaled/systemic steroids (whatever the indication) within 4 weeks prior to Visit 1 (Screening), or with long acting systemic corticosteroids 12 weeks before Visit 1 (Screening).
* Patients under continuous corticotherapy (inhaled or systemic drugs).
* Patients following a strict low sodium diet as the study treatment contains 590 mg of sodium chloride per vial in a 10 mL solution.
* Investigators, co-Investigators, as well as their children or spouses and all study collaborators.
C: Inclusion Criteria:

* Diagnosed with eczema (atopic dermatitis)
* Family history of eczema, allergic rhinitis, or asthma
* Allergy to one or more of the following: egg white, cow's milk, peanut, or soybean
* Weigh at least 9.5 kg (20.9 lbs)
* Parent or guardian willing to provide informed consent

Exclusion Criteria:

* Allergy to house dust mite, cat, or timothy grass
* Born prematurely (before 36th week's gestation)
* Previous diagnosis of asthma OR have had 3 or more distinct episodes of wheeze during the first year of life
* Chronic pulmonary disease
* Chronic disease requiring therapy
* Past or current treatment with systemic immunomodulator medication
* Past or current treatment with allergen-specific immunotherapy
* Received 10 or more days of systemic steroids in the 3 months prior to study entry
* Orofacial abnormalities that are likely to interfere with the subject's ability to take study treatment
* Participated in another clinical study within the 3 months prior to study entry
D: Inclusion Criteria:

* allergic rhinitis and/or
* mild stable asthma
* house dust mite allergic
* positive HDM-specific IgE as determined by skin prick test (wheal diameter \>6 mm to D. pteronyssinus) or CAP-Pharmacia score \> 2

Exclusion Criteria:

* Immunodeficiency diseases
* Severe or uncontrolled asthma
* Previous immunotherapy with House dust mite (HDM) extract within the last five years or ongoing immunotherapy with HDM or other allergens
* Continuous oral corticosteroids
* Subjects on treatment with beta-blockers
* Pregnant women

Answer: C