Publications by authors named "Svetlana Bizjajeva"
Background: A substantial unmet need remains for safe and effective vaccines against dengue virus disease, particularly for individuals who are dengue-naive and those younger than 9 years. We aimed to assess the efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (TAK-003) in healthy children aged 4-16 years.
Methods: We present data up to 18 months post-vaccination from an ongoing phase 3, randomised, double-blind trial of TAK-003 in endemic regions of Asia and Latin America (26 medical and research centres across Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand).
Background: Dengue, a mosquito-borne viral disease, was designated a World Health Organization top 10 threat to global health in 2019.
Methods: We present primary efficacy data from part 1 of an ongoing phase 3 randomized trial of a tetravalent dengue vaccine candidate (TAK-003) in regions of Asia and Latin America in which the disease is endemic. Healthy children and adolescents 4 to 16 years of age were randomly assigned in a 2:1 ratio (stratified according to age category and region) to receive two doses of vaccine or placebo 3 months apart.
Objective: To demonstrate the potential of an MF59-adjuvanted inactivated trivalent seasonal influenza vaccine (aIIV3; Fluad™) to improve the immune response in young children, we review the immunogenicity, efficacy, and safety/tolerability of aIIV3 from a comprehensive clinical development program in a pediatric population with a specific need for improved influenza vaccines.
Methods: Data were analyzed from a series of 1 phase Ib, 3 phase II, and 2 phase III studies involving 11,942 children aged 6 months through 5years.
Results: The clinical data showed that aIIV3 had statistically significantly greater immunogenicity and efficacy in the prevention of influenza compared to conventional inactivated trivalent seasonal influenza vaccines (IIV3s).
Objective: To assess the safety and immunogenicity of the MF59-adjuvanted seasonal trivalent inactivated influenza vaccine (aIIV3; Fluad) in children aged 6 months through 5 years who are at risk of influenza complications.
Methods: A retrospective analysis was performed to examine unsolicited adverse events (AEs) in an integrated dataset from six randomized clinical studies that compared aIIV3 with non-adjuvanted inactivated influenza vaccines (IIV3). The integrated safety set comprised 10 784 children, of whom 373 (3%) were at risk of influenza complications.
Background: Patients with the later-onset IVS4+919G>A (IVS4) Fabry mutation are known to have positive central nervous system involvement compared with age- and sex-matched controls. This study compares central nervous system manifestations in patients with the IVS4 mutation or classical Fabry mutations.
Methods: This was a retrospective analysis of magnetic resonance imaging (MRI) data from Taiwanese patients enrolled in the Fabry Outcome Survey (sponsored by Shire; data extracted March 2015).
We retrospectively evaluated correlations between cardiac manifestations and globotriaosylceramide (Gb3) accumulation in cardiomyocytes from Taiwanese patients with Fabry disease and the IVS4+919G>A (IVS4) mutation who underwent endomyocardial biopsy (Shire; Fabry Outcome Survey data; extracted January 2015). Of 24 males and six females (median age [Q1; Q3] at biopsy 60.4 [57.
View Article and Find Full Text PDFBackground: Ocular signs of Fabry disease can be seen in the first decade of life.
Methods: We examined the occurrence of ocular signs in 232 paediatric patients in the Fabry Outcome Survey (FOS) international registry and looked for relationships between the presence of eye findings and disease severity as measured by the FOS Mainz severity score index (FOS-MSSI).
Results: At least one ocular sign was found in 55/101 (54.
Baseline demographic and phenotypic characteristics of patients aged ≥50years in the Fabry Outcome Survey (Shire; data extracted June 2014) were compared with younger adults to investigate potential factors influencing treatment decisions in later life. Age groups were defined using age at treatment initiation or at FOS entry for untreated patients: 18-49 (n=1344; 49.5% male; 64.
View Article and Find Full Text PDFBackground: Non-adjuvanted seasonal influenza vaccines show only modest efficacy in young children. This study compared the immunogenicity, reactogenicity and safety of the MF59-adjuvanted trivalent subunit vaccine (aTIV) with two non-adjuvanted trivalent vaccines, TIV-1, the non-adjuvanted version of aTIV, and TIV-2, a split virion vaccine.
Methods: 6078 children received two doses of aTIV (n=3125), TIV-1 (n=1479), or TIV-2 (n=1474) four weeks apart (Days 1 and 29).
Aim: To study which eye-screening protocol prevails in Swedish maternity/neonatal wards, evaluate efficacy in a prospective study and compare results with earlier Swedish retrospective results.
Methods: Surveys were sent in 2006 to maternity/neonatal and women's health departments regarding screening policy. Response frequency was 96% (122/127).
Objectives: The aim of this paper was to compare selected indication parameters for patients scheduled for hip and knee replacement at orthopaedic units in Sweden.
Methods: Swedish orthopaedic clinics performing joint replacement were invited to enroll in the study. The study time was set to 2 years (from June 2006 to June 2008).
Background And Purpose: The number of national arthroplasty registries is increasing. However, the methods of registration, classification, and analysis often differ.
Methods: We combined data from 3 Nordic knee arthroplasty registers, comparing demographics, methods, and overall results.