Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female, \>=18 to \<=75 years old.
• Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film
• Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up
• Women of childbearing age must have an effective contraception during the first 9 months of the study.
• Participants must give written consent prior to any trial procedure
• Participants must be covered by social security regimen or equivalent.
• Participants will be followed during the 4 years from the inclusion visit.
Locations
Other Locations
France
I-REIVAC/CIC1417 Cochin Hospital, AP-HP
RECRUITING
Paris
Contact Information
Primary
Odile LAUNAY, MD,PhD
odile.launay@aphp.fr
+33(01)58 41 28 58
Backup
Audrey BECLIN-CLABAUX
audrey.clabaux@aphp.fr
+33 (0)1 58 41 33 82
Time Frame
Start Date:2022-09-15
Estimated Completion Date:2028-10
Participants
Target number of participants:84
Treatments
Other: Arm A : Trumenba®: Standard vaccination
Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose.
Other: Arm B:Bexsero®: standard vaccination regimen
Two doses of 0.5 ml each at one month intervals
Other: Arm C : Bexsero® Innovative vaccine strategy
Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose.