A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years
Condition: MENINGOCOCCAL INFECTION
MeSH terms: Meningococcal Infections
Intervention: Bivalent rLP2086 Vaccine; Licensed pediatric hepatits A vaccine; Normal Saline
Intervention description: 1 dose of 120 μg of bivalent rLP2086 by intramuscular injection at Months 0, 2, and 6 into the upper deltoid muscle of the arm.; 1 0.5 mL dose by intramuscular injection at Months 0 and 6 into the upper deltoid muscle of the arm.; Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose 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: 400.0
Sex: All
Minimum age: 24 Months
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is looking at a new vaccine that might prevent meningococcal disease, and will
      study the immune response elicited by this vaccine when given to healthy young children. The
      study will also look at the safety of the new vaccine as well as how it is tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Evidence of a personally signed and dated informed consent document (ICD) indicating
             that the subject's parent(s)/legal guardian has been informed of all pertinent aspects
             of the study.

          2. Parent(s)/legal guardian and subject who are willing and able to comply with scheduled
             visits, vaccine regimen, laboratory tests, and other study procedures.

          3. Male or female subjects aged ≥24 months and <10 years at time of randomization,
             stratified equally by age (≥24 months to <4 years or ≥4 years to <10 years).

          4. Subject is available for the entire study period and subject's parent(s)/legal
             guardian can be reached by telephone.

          5. Healthy subject as determined by medical history, physical examination, and judgment
             of the investigator.

          6. Subject must have received all vaccinations in the relevant national immunization
             program (NIP) for their age group.

          7. Male and female subjects of childbearing potential and at risk for pregnancy must
             agree to use a highly effective method of contraception throughout the study. A
             subject is of childbearing potential if, in the opinion of the investigator, he/she is
             biologically capable of having children and is sexually active.

          8. Negative urine pregnancy test for all female subjects who are biologically capable of
             having children.

        Exclusion Criteria:

          1. Previous vaccination with any meningococcal serogroup B vaccine.

          2. Subjects who have received prior HAV vaccination.

          3. Contraindication to vaccination with any HAV vaccine or known latex allergy.

          4. Subjects receiving any allergen immunotherapy with a nonlicensed product or subjects
             receiving allergen immunotherapy with a licensed product and who are not on stable
             maintenance doses.

          5. A previous anaphylactic reaction to any vaccine or vaccine-related component.

          6. Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection.

          7. A known or suspected defect 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, those receiving chronic systemic (oral, intravenous, or intramuscular)
             corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with
             terminal complement deficiency may be included. Additional details will be provided in
             the study reference manual (SRM).

          8. History of microbiologically proven disease caused by N meningitidis or Neisseria
             gonorrhoeae.

          9. Significant neurological disorder or history of seizure (excluding simple febrile
             seizure).

         10. Receipt of any blood products, including immunoglobulin, within 6 months before the
             first study vaccination.

         11. Current chronic use of systemic antibiotics.

         12. Participation in other studies involving investigational product(s)/device(s) (Phases
             1-4) within 28 days before administration of the first study vaccination.
             Participation in purely observational studies is acceptable.

         13. Any neuroinflammatory or autoimmune condition, including but not limited to transverse
             myelitis, uveitis, optic neuritis, and multiple sclerosis.

         14. Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results and, in the judgment of the investigator, would make the subject
             inappropriate for entry into this study.

         15. Pregnant female subjects, breastfeeding female subjects, male subjects with partners
             who are currently pregnant, or male and female subjects of childbearing potential who
             are unwilling or unable to use a highly effective method of contraception as outlined
             in this protocol for the duration of the study.

         16. Subjects who are children of investigational site staff members directly involved in
             the conduct of the study and their family members, subjects who are children of site
             staff members otherwise supervised by the investigator, or subjects who are children
             of Pfizer employees directly involved in the conduct of the study.