Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis.

Introduction: The currently licensed quadrivalent MenACWY-CRM conjugate vaccine presentation consists of two vials (lyophilized MenA and liquid MenCWY) to be reconstituted before injection. A new fully liquid, single-vial formulation has been developed to simplify administration and prevent reconstitution errors. We present pooled safety data from two randomized, controlled, observer-blind phase 2b clinical trials, in which the fully liquid presentation was compared with the licensed presentation.

Immunological non-inferiority of a new fully liquid presentation of the MenACWY-CRM vaccine to the licensed vaccine: results from a randomized, controlled, observer-blind study in adolescents and young adults.

A fully liquid MenACWY-CRM vaccine presentation has been developed, modifying the meningococcal serogroup A (MenA) component from lyophilized to liquid. The safety and immunogenicity of the liquid presentation at the end of the intended shelf-life (aged for 24 or 30 months) were compared to the licensed lyophilized/liquid presentation. This multicenter, randomized (1:1), observer-blind, phase 2b study (NCT03433482) enrolled adolescents and young adults (age 10-40 years).

Evaluation of exercise testing for subjects with isolated proteinuria and/or hematuria of unclear significance.

Background: A frequent problem that family doctors face is the meaning of small quantities of blood or protein in urine samples. Patients with this problem are often either neglected or referred to specialists for complex, expensive, and often invasive diagnostic procedures. Exercise testing has never been considered in nephrology, except for some attempts in diabetic patients.

The self-locating catheter: clinical experience and follow-up.

Background: The self-locating catheter invented by Nicola Di Paolo has been used increasingly in Italy and elsewhere since 1994, with about a thousand patients currently implanted every year. Twelve grams of tungsten inserted into the tip of the conventional Tenckhoff catheter during extrusion does not significantly change its form, but suffices to keep the tip firmly in the Douglas cavity.

Objective: The aim of the present study was to confirm our preliminary results in a large population of peritoneal dialysis patients.