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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513649-35-00

Acronym

P170938J

Enrollment

Registered

2024-08-09

Start date

2022-09-15

Completion date

Unknown

Last updated

2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asplenia

Brief summary

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.

Interventions

DRUGBexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA

DRUGcomponent

DRUGadsorbed)

DRUGTrumenba suspension for injection in pre-filled syringe Meningococcal group B vaccine (recombinant

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026