EU Clinical Trials Register - Phase 3 Trials

H1N1v Vaccination of Pregnant Women: Longitudinal Cohort Study, Denmark, Phase 3

COPSAC (a non-commercial Danish sponsor) conducted a Phase 3 longitudinal cohort study in Denmark to evaluate the immune response and safety of the Novartis MF59-adjuvanted H1N1 vaccine Focetria in pregnant women during their second and third trimesters. The trial tracked immune persistence over a 15-month period following a single maternal vaccination and assessed maternally transferred H1N1-specific antibodies in newborns. The EudraCT registration was first entered on 30 October 2009 and the trial status is now Completed.

Phase III IV Iron Trial for Anaemia in Major Surgery (PREVENTT)

A randomised double-blind controlled Phase III clinical trial registered with EudraCT number 2012-002786-35, sponsored by University College London (Non-Commercial) and funded by the NIHR Health Technology Assessment programme. The trial compares the efficacy and safety of intravenous ferric carboxymaltose (Ferinject) with placebo in patients with iron deficiency anaemia undergoing major open abdominal surgery. The primary objective is to determine whether a single preoperative dose of intravenous iron reduces the need for peri-operative blood transfusion within 30 days post-operation. Trial status: Completed.

STOP-FLU Influenza Prevention Organ Transplant Phase 3 Trial

The EU Clinical Trials Register has published registration details for EudraCT 2019-001974-27, the Phase 3 STOP-FLU trial titled 'Reducing the Burden of Influenza after Solid-Organ Transplantation.' The non-commercial trial is sponsored by Centre Hospitalier Universitaire Vaudois (CHUV) in Switzerland with funding from the Swiss National Science Foundation, and is being conducted at sites in Spain under AEMPS oversight. The trial compares adjuvanted influenza vaccine Fluad (test IMP) against standard inactivated vaccine VaxigripTetra (comparator) in solid organ transplant recipients, with a focus on assessing immunological response in immunocompromised patients.