Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA
Sponsors
Apellis Pharmaceuticals Inc., GlaxoSmithKline Biologicals, Medical University of Vienna, Sanofi Pasteur Inc., Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Conditions
AspleniaC3 glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN)Chronic spontaneous urticariaGeneralized Myasthenia GravisGeneralized Myasthenia Gravis and Ocular Myasthenia GravisHealthy volunteersInfectionsInvasive meningococcal disease (IMD)
Phase 1
A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine when Administered to Healthy Infants
CompletedCTIS2023-506449-40-00
Start: 2021-11-29End: 2025-11-21Target: 497Updated: 2025-09-01
A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate A) the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of IM-101 in Adult Participants with Generalized Myasthenia Gravis, and B) the Efficacy and Safety of Treatment of IM-101 in Adult Participants with Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
Not yet recruitingCTIS2025-522406-20-00
Target: 51Updated: 2026-02-18
Phase 2
Immunogenicity and safety of a meningococcal serogroup B vaccine in adult patients with asplenia
RecruitingCTIS2023-508192-36-00
Start: 2024-03-05Target: 80Updated: 2025-01-02
A PHASE 2, RANDOMIZED, BLINDED, PLACEBOCONTROLLED, STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOMETRICS, AND EFFICACY OF DNTH103 IN ADULTS WITH GENERALIZED MYASTHENIA GRAVIS (MAGIC)
RecruitingCTIS2024-512865-15-00
Start: 2024-09-03Target: 54Updated: 2025-10-27
Proof of concept study to assess the efficacy and safety of Danicopan (factor D inhibitor) in adult patients with chronic spontaneous urticaria resistant to H1-antihistamine treatment (DANICSU).
CompletedCTIS2024-512386-14-00
End: 2024-10-20Target: 24Updated: 2024-09-24
A parallel-group prevention, Phase II, partially blinded, multi-stage study to investigate the immunogenicity and safety of Pentavalent Meningococcal ABCYW Vaccine formulations compared with licensed meningococcal vaccines when administered alone in healthy children (2 to 9 years of age) or concomitantly with routine pediatric vaccines in toddlers (12 to 15 months of age) and infants (2 months of age).
Active, not recruitingCTIS2023-510465-10-00
Start: 2025-03-10Target: 250Updated: 2025-11-13
Phase 3
An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis (VALE)
Active, not recruitingCTIS2023-504625-39-00
Start: 2023-05-18Target: 66Updated: 2026-01-08
SPLEMENGO - Multicenter, randomized, phase III, trial assessing the immunogenicity and safety of three meningococal B vaccine strategies among patients with asplenia
Active, not recruitingCTIS2024-513649-35-00
Start: 2022-09-15Target: 84Updated: 2024-08-09
A Phase 3b, open-label, multi-center study to assess the immune response and safety of the meningococcal group B vaccine rMenB+OMV NZ when administered to healthy participants aged 10 to 20 years old, who were primed during the first 2 years of life
Active, not recruitingCTIS2024-519549-31-00
Start: 2025-09-05Target: 247Updated: 2025-11-07