Rationale Allergen sensitization is an important risk factor for allergic disease, including allergic rhinitis. This study reports the sensitization status, and efficacy of fexofenadine (FEX), in a subset of children (aged 6–11 yrs) from Europe with seasonal allergic rhinitis (SAR) enrolled into a placebo-controlled, randomized, parallel-group study. Methods For randomization, children required a positive skin prick test to at least one pollen allergen for the current season and condordance to that specific allergen in in vitro IgE testing. Specific IgEs were determined by the Fluoro Enzyme Immuno Assay; positive IgE was defined as IgE class ≥2 (>0.7 kUA/L). Analysis was performed on the modified intention-to-treat (mITT) population, treated with either FEX HCl 30 mg BID or placebo. Efficacy was evaluated as the overall mean change from baseline in 12-hour reflective total symptom score (TSS). Results A subset of 375 subjects (FEX, n=187; placebo, n=188), from 42 centers in Finland, France, Germany, Italy, Poland and Spain, was analyzed from a total of 148 centers in 15 countries. Sensitization to pollen allergens assessed by plant category showed that grasses were the most common group of allergens (74.9% FEX; 79.8% placebo); sensitization to trees and weeds were evenly distributed (trees: 23.5% FEX, 23.9% placebo; weeds: 31.6% FEX, 26.1% placebo). FEX significantly improved the mean change from baseline in TSS compared with placebo ( p<0.01). Conclusions In this subset of children from Europe, grasses were the most common sensitizing allergen. Furthermore, FEX significantly improved the symptoms of SAR in this population of children.