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

NCT04166656 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-11-20

No results posted yet for this study

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

Interventions

BIOLOGICAL

Trumenba®

Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled.

BIOLOGICAL

Bexsero®

Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe

Sponsors & Collaborators

  • EUCLID Clinical Trial Platform

    collaborator OTHER

  • Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

    collaborator OTHER

  • CIC 1417 Cochin-Pasteur

    collaborator OTHER

  • Innovative clinical research in vaccinologie (I-REIVAC)

    collaborator UNKNOWN

  • Institut Pasteur

    collaborator INDUSTRY

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Odile LAUNAY, MD,PhD · CIC 1417 Clinical Center Investigation

  • MUHAMED-KHEIR TAHA, MD, PHD · Institut Pasteur

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2028-09-30
Completion
2028-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04166656 on ClinicalTrials.gov