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Studies

Interventional Recruiting Phase 3

NCT04166656 on ClinicalTrials.gov

Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.

Official title: Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia

  • Sponsor: Assistance Publique - Hôpitaux de Paris
  • Collaborators: EUCLID Clinical Trial Platform, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne, CIC 1417 Cochin-Pasteur, Innovative clinical research in vaccinologie (I-REIVAC), Institut Pasteur, URC-CIC Paris Descartes Necker Cochin
  • Enrollment: 84 (Estimated)
  • Study start: 2022-09-15 (Actual)
  • Primary completion: 2028-09-01 (Estimated)
  • Study completion: 2028-10-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Prevention

Brief Summary

The purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection.

Conditions

  • Splenectomy

Intervention / Treatment

  • Biological: Trumenba®
  • Biological: Bexsero®

Primary Outcome Measures

  • Proportion of responders defined as participants with seroconversion (One month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.)
    Proportion of responders defined as participants with seroconversion (i.e. hSBA titer increases from \<4 before vaccination to at least 4) or with hSBA titer showing a 4-fold increase (if hSBA titer was at least 4 before vaccination) one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.

Countries

France

Locations and Investigators

  • Centre Hospitalier Universitaire De Lille, Lille, France
    • Dominique, DEPLANQUE
  • Centre Hospitalier Universitaire De Dijon, Dijon, France
    • Lionel, PIROTH
  • Assistance Publique Hopitaux De Paris, Paris Cedex 18, France
    • Xavier, DUVAL
  • Assistance Publique Hopitaux De Paris, Clichy, France
    • Agnès, LEFORT
  • University Hospital Of Clermont-Ferrand, Clermont Ferrand Cedex 1, France
    • Violaine, CORBIN-VALDENAIRE
  • Centre Hospitalier Annecy Genevois, Pringy Cedex, France
    • Cécile, JANSSEN
  • Assistance Publique Hopitaux De Paris, Paris, France
    • Odile, LAUNAY
  • Hospices Civils De Lyon, Lyon Cedex 04, France
    • Anne, CONRAD
  • Centre Hospitalier Universitaire De Saint Etienne, Saint Priest En Jarez, France
    • Elisabeth, BOTELHO-NEVERS
  • Centre Hospitalier Universitaire D'Angers, Angers, France
    • Vincent, DUBEE
  • Centre Hospitalier Universitaire De Caen Normandie, Caen Cedex 9, France
    • Jocelyne, MICHON
  • Centre Hospitalier Universitaire De Nantes, Nantes, France
    • Maeva, LEFEBVRE
  • Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 9, France
    • Enkelejda, HODAJ
  • Centre Hospitalier Departemental Vendee, La Roche Sur Yon Cedex 9, France
    • Thomas, GUIMARD
  • Centre Hospitalier Universitaire De Rennes, Rennes, France
    • Fabrice, LAINE
  • Centre Hospitalier Regional De Marseille, Marseille, France
    • Bertrand, DUSSOL
  • Centre Hospitalier Universitaire Rouen, Rouen Cedex, France
    • Marie-Pierre, TAVOLACCI
  • Centre Hospitalier Universitaire De Montpellier, Montpellier Cedex 5, France
    • Alain, MAKINSON
  • Les Hopitaux Universitaires De Strasbourg, Strasbourg, France
    • Catherine, MUTTER
  • Centre Hospitalier Regional Et Universitaire De Brest, Brest, France
    • Sylvain, JAFFUEL

Study Officials