1,025
Participants
Start Date
July 20, 2015
Primary Completion Date
November 9, 2018
Study Completion Date
November 19, 2018
Short ragweed pollen allergen extract
One sublingual tablet containing 12 units of Amb a 1-U, once daily (QD) for up to 35 weeks.
Placebo
One placebo sublingual tablet, QD for up to 35 weeks.
Self-injectable epinephrine
Intramuscular (IM) injection with suggested doses of 0.15 mg for participants weighing 15-30 kg (33-66 pounds) or 0.3 mg for participants weighing ≥30 kg (≥66 pounds), as needed for severe allergic reactions. Epinephrine was only provided in countries/study sites where it was a regulatory requirement.
Albuterol/Salbutamol
Inhalation of albuterol 90 mcg/puff or salbutamol 100 mcg/puff metered dose inhaler (MDI), as needed as asthma rescue medication for those participants with asthma
Loratadine
5 mg (1 mg/mL syrup or 5 mg tablet) for participants 5 years old or 10 mg (1 mg/mL syrup or 10 mg tablet) for participants 6 to 17 years old, as needed for rhinoconjunctivitis symptoms
Olopatadine
Opthalmic solution, 1 drop (0.1%) per affected eye twice daily (BID), as needed for rhinoconjunctivitis symptoms
Mometasone furoate monohydrate
Intranasal spray, at doses of 1 spray (50 mcg/ spray) per nostril for participants 5 to 11 years old or 2 sprays (50 mcg/spray) per nostril for participants 12 to 17 years old, as needed for rhinoconjunctivitis symptoms
Merck Sharp & Dohme LLC
INDUSTRY