Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
Condition: Meningococcal B Disease
Intervention: rLP2086 vaccine; Pediatric HAV vaccine
Intervention description: 60 mcg or 120mcg at 0, 2 and 6 months; 0.5-mL dose at months 0 and 6. Normal saline at month 2.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 396.0
Sex: All
Minimum age: 12 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase 2 Immunogenicity; Safety; Tolerability Study; rLP2086 Vaccine; Healthy Toddlers; Neisseria meningitidis; Duration of Immunogenicity

Summary:

      The purpose of this study is to investigate the immunogenicity, safety and tolerability of a
      new vaccine that might prevent meningococcal B disease. The study will be conducted in
      healthy toddlers aged between 12 and 24 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject aged 12 to <15 months or 18 to <24 months during
             sentinel-cohort enrollment, Or,12 to <24 months during expanded-cohort enrollment.

          -  Subjects must have received all vaccinations in the relevant National Immunization
             Program (NIP) for their age group.

          -  Subject is determined to be in good health by medical history, physical examination,
             and judgment of the investigator.

        Exclusion Criteria:

          -  Previous vaccination with any meningococcal serogroup B vaccine.

          -  Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine
             during Stage 1 of the study.

          -  Contraindication to vaccination with any HAV vaccine or known latex allergy.

          -  A previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection.

          -  A known or suspected disorder of the immune system that would prevent an immune
             response to the vaccine, such as subjects with congenital or acquired defects in
             B-cell function or those receiving systemic immunosuppressive therapy. Subjects with
             terminal complement deficiency may be included.

          -  History of microbiologically proven disease caused by N meningitidis or Neisseria
             gonorrhoeae.

          -  Significant neurologic disorder or history of seizure (excluding simple febrile
             seizure).

          -  Receipt of any blood products, including immunoglobulin, within 6 months before the
             first study vaccination until the end of Stage 1.

          -  Current chronic use of systemic antibiotics.

          -  Received any investigational drugs, vaccines or devices within 28 days before
             administration of the first study vaccination and/or during study participation.

          -  Any neuroinflammatory or autoimmune condition, including but not limited to transverse
             myelitis, uveitis, optic neuritis, and multiple sclerosis.