7 results
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…
Primary Objective:* To determine the efficacy of silver impregnated dressings compared to a topical antibiotic to treat patients with PEG-site infections.Secondary Objectives:* To investigate the reduction and or change in stomal bacterial profile…
The study will be performed in 3 parts, Parts 1, 2 and 3. In all parts, the purpose is to investigate to what extent APX001 is tolerated. In addition, it will be investigated how quickly and to what extent APX001 is absorbed and eliminated from the…
This study is designed to dissect the immune response after Bp booster vaccination by investigating the kinetics of innate and adaptive immune cells, and detection and characterization of Bp-specific memory B cells and plasma cells.
Primary objective;Confirm superiority of IgG antibody levels against pertussis toxin (Ptx), present in the acellular vaccines, in infants at the age of 3 months of mothers having received a pertussis vaccine during pregnancy versus infants of…
*Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?*
Our primary objective is to evaluate non-inferiority of anti-Pertussis Toxin (PT) IgG in term infants at 2m of age born of mothers having received a pertussis vaccine between 20-24w Gestational Age (GA) compared to a reference anti-PT IgG at 2m of…
The main purpose of this study is to investigate the longitudinal effects of an aP booster vaccination in adults, on long-term humoral and cellular memory immunity against B. pertussis. By measuring antibody levels against the various pertussis…