Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants

• Status: Recruiting
• Trial end date: 2025-07-23

Summary

Primary Objective:

• To describe the safety profile of the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines in healthy adults, adolescents, toddlers and infants, when administered alone (Stages 1-4) or concomitantly with MenQuadfiTM (MenACYW conjugate vaccine) (for Stages 2-4 only), and with age-appropriated routine pediatric vaccines (for Stages 3-4 only)

1. To describe the safety profile of the SP MenB vaccine formulations, Bexsero Vaccine and Trumenba Vaccine in healthy adults, and adolescents;

2. To describe the safety profile of the SP MenB vaccine formulations and Bexsero Vaccine in toddlers and infants;

3. To describe the safety profile of the SP MenB vaccine formulations,

• when administered alone

• when administered with MenQuadfiTM (MenACYW conjugate vaccine)

• when administered with routine infant immunizations

• To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines after the last dose of primary vaccination in healthy adults, adolescents, toddlers and infants, when administered alone, or concomitantly with MenQuadfi Vaccine or other routine vaccines, as measured by the serum bactericidal assay using human complement (hSBA) in the primary panel of MenB strains by Stage, by age group and by vaccine schedule

Secondary Objective:

• To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines at each timepoint in healthy adults, adolescents, toddlers and infants, when administered alone or concomitantly with MenQuadfi Vaccine or other routine vaccines as measured by hSBA in the primary panel of MenB strains by Stage by age group and by vaccine schedule

• To describe the immune response (breadth of coverage) in the secondary panel of MenB strains in participants (adults and adolescents) in Stage 1 and 2 after the last dose of the primary series in each group

• To describe the persistence of immune response following primary series at D366, and immune response 1 month after a booster dose of the SP MenB vaccine given 1-year post-dose 1 (at D366) in a subset of adults and adolescents in Stage 2 who received SP MenB vaccine formulations, Bexsero Vaccine or Trumenba Vaccine as measured by hSBA in the primary panel of MenB strains by age group

• To describe the immune response against meningococcal serogroups A, C, W and Y measured with hSBA in participants from each agegroup receiving MenQuadfi Vaccine

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Sanofi Pasteur, a Sanofi Company
• Treatments: Vaccines