Multicenter, randomized, phase III, trial assessing the immunogenicity and safety of three meningococal B vaccine strategies among patients with asplenia

Phase 1

• Conditions: asplenic patients at risk for invasive meningococcal disease; MedDRA version: 20.0Level: PTClassification code 10041642Term: SplenectomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-000924-17-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-19
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Male or female, >=18 to <=75 years old.
2. Asplenic patient (for at least 2 weeks) with Howell Jolly bodies
visible on blood film and splenectomy confirmed by ultrasound.
3. Women of childbearing age must have an effective contraception
during the first 9 months of the study.
4. Participants must give written consent prior to any trial procedure.
5. Participants must be covered by social security regimen or
equivalent.
6. Participants will be followed during the 4 years from the inclusion
visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

1. History of meningococcal vaccination.
2. History of anaphylaxis post vaccination.
3. Known allergy to any components (active substances or excipients)
of both vaccines.
4. Patients who cannot stop antibiotics 7 to 10 days before blood
collection.
5. Participants who have received any another vaccines within 4 weeks
prior to immunization or who are planning to receive any vaccine within
the first 9 months of the study (excepted annual influenza vaccination
which is permitted 4 weeks before and after each vaccination visit of the
study and then allowed at any time during the study follow up).
6. Parenteral Ig within the 3 months prior to VS or planned during the
study.
7. Chemotherapy agents within 6 months prior M0 or planning to take
any during the study.
8. Steroids (> 10mg/day; > 14 days) within the month preceding M0 or
planning to take any during the study.
9. Any pathology or condition that may impair the immune response,
apart from splenectomy: immunosuppressive therapy in progress or in
the 6 months prior to inclusion, hematopoietic stem cells allo /autograft, primary immunodeficiency, nephrotic syndrome, evolutive
cancer, cirrhosis, known infection to HIV;
10. Thrombocytopenia or any coagulation disorder contra-indicating
intramuscularly injections.
11. Pregnancy, breastfeeding or positive pregnancy test up to 9 months
after inclusion.
12. Severe acute febrile illness within the week before inclusion.
13. Registration for any other clinical trial throughout the trial period
except observational study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified