Results from a large post-marketing safety surveillance study in the Republic of Korea with a quadrivalent meningococcal CRM-conjugate vaccine in individuals aged 2 months-55 years.

The quadrivalent meningococcal conjugate vaccine MenACWY-CRM is approved in the Republic of Korea for use in individuals from 2 months of age. This single-arm, open-label, observational, multicenter, post-marketing study (NCT01766206) assessed the safety of MenACWY-CRM vaccine administered according to local clinical practice. A total of 3939 individuals aged 2 months-55 years provided safety data post-vaccination; the analysis was conducted on the per-protocol set (3920 participants). Solicited and unsolicited adverse events (AEs) were collected over 7 days post-vaccination and medically-attended AEs (MAAEs) and serious AEs (SAEs) over 29 days post-vaccination. Among recorded solicited AEs, injection site AEs were reported by 21.38% of participants, with tenderness/pain being most frequent across age groups; systemic AEs were reported in 13.95% of participants, with irritability (in ˂6-year-olds), headache and myalgia (in ≥6 year-olds) being the most frequently reported. Most solicited AEs were mild or moderate in nature. The percentage of participants reporting unsolicited AEs varied in the study population, i.e. 12.56% in participants aged 2-23 months and 3.18% in those ≥2 years of age. Overall, less than 22% of unsolicited AEs were considered as related to vaccination. MAAEs (10.89% of participants) were mostly mild; 2.82% were considered as related to vaccination. Three (0.46%) and 5 (0.15%) SAEs (none vaccination-related) occurred in participants aged 2-23 months and 2-55 years, respectively. No deaths were reported. The safety profile for MenACWY-CRM in this post-marketing surveillance was consistent with observations from studies conducted during the vaccine's clinical development, with no new safety concerns.

Food sensitization in infants and young children with atopic dermatitis.

Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disease. Children with AD tend to have a higher prevalence of food allergies. This study investigated the clinical significance of food sensitization in AD patients. A total of 266 AD patients participated in this study. The prevalence of food sensitization and clinically relevant sensitization were compared in the subjects according to their age and AD severity. Sera from all patients were analyzed for food-specific IgE levels using the Pharmacia CAP System FEIA. The serum specific IgE levels for egg, milk, peanut and soybean were measured. Patients were regarded as sensitized to the food if their food-specific IgE levels were above 0.35 kUA/L. Also the food-specific IgE levels, the so-called diagnostic decision point, which is recommended as the clinically relevant level, for clinical food allergy, as suggested by Sampson et al, was used as an alternative method. From the measurement of food-specific IgE antibodies of the four foods, egg was the most highly sensitized and the main causative allergenic food in children with AD. The positive rates of specific IgE to the four major food allergens, and the prevalences of clinically relevant food sensitization, were higher for all foods tested in the group less than 1 year of age, and were significantly higher in moderate to severe AD compared to mild AD in infants and young children. In summary, presence of food specific IgE is prevalent in infants and young children with AD, and clinically relevant food sensitization is important in Korean infants and children with moderate to severe AD.