Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of
      a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously
      primed with rMenB+OMV NZ according to two different three-dose immunization schedules in
      infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will
      also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following
      the two different immunization schedules, in order to identify the optimal timing for
      boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12
      (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort
      of subjects enrolled). These subjects will generate data for assessing the safety and
      immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls
      for a descriptive comparison of antibody persistence and booster responses for the other
      groups.
    


Intervention name(s): rMenB+OMV NZ with routine vaccinations; rMenB+OMV NZ with routine vaccinations; rMenB+OMV NZ; rMenB+OMV NZ; rMenB+OMV NZ with routine vaccinations; rMenB+OMV NZ with routine vaccinations; two doses of rMenB+OMV NZ; rMenB+OMV NZ with routine vaccinations; two doses of rMenB+OMV NZ; rMenB+OMV NZ; two doses of rMenB+OMV NZ; rMenB+OMV NZ with routine vaccinations
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age; rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age; rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age; rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age; rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 months of age; rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 18 months of age; two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age.; rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age; two catch-up doses of rMenB+OMV NZ at 18 and 20 months of age; rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age; two catch-up doses of rMenB+OMV NZ at 24 and 26 months of age; rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 (Group 3a), 18 (Group 3b) or 24 (Group 3c) months of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal meningitis; prevention; vaccination; toddler