Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: meningococcal B rLP2086 vaccine; Routine age appropriate childhood vaccines; meningococcal B rLP2086 vaccine; Routine age appropriate childhood vaccines; Routine age appropriate childhood vaccines
Intervention description: vaccination; vaccination; vaccination; vaccination; vaccination
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: No
Keywords: Meningococcal B vaccine; infants; safety; immunogenicity

Summary:

      The primary purpose of this study is to evaluate the safety and immunogenicity of an
      investigational meningococcal B vaccine in healthy infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Investigators should always use good clinical judgment in considering a subject's
             overall fitness for trial participation. In addition, any condition that in the
             opinion of the investigator may interfere with the evaluation of study objectives
             should be carefully considered prior to enrolling subjects.

          -  Male or female subjects aged 2 months (42 to 98 days of age) at the time of
             enrollment.

          -  Available for the entire consented period and whose parent/legal guardian can be
             reached by telephone.

          -  Healthy infant as determined by medical history, physical examination, and judgment of
             the investigator.

          -  Parent/legal guardian must be able to complete all relevant study procedures during
             study participation.

        Exclusion Criteria:

          -  Previous vaccination with licensed or investigational vaccines: meningococcal B,
             meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis,
             poliovirus, rotavirus, varicella, measles, mumps, or rubella.

        Any of the following illnesses/conditions that, in the investigator's judgment, will
        substantially increase the risk associated with the subject's participation in and
        completion of the study:

          -  A previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal,
             Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus,
             rotavirus, varicella, measles, mumps, or rubella.

          -  Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection.

          -  Known or suspected immune deficiency or suppression.

          -  History of culture-proven invasive disease caused by N meningitidis or Neisseria
             gonorrhoea.

          -  Major known congenital malformation or serious chronic disorder.

          -  Significant neurological disorder or history of seizure including febrile seizure, or
             significant stable or evolving disorder such as cerebral palsy, encephalopathy,
             hydrocephalus, or other significant disorder.

        Does not include resolving syndromes due to birth trauma such as Erb palsy.

          -  Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and
             monoclonal antibodies).

          -  Received any investigational drugs, vaccines or devices (aside from those specified in
             the protocol) within 4 weeks before administration of the first dose of test article
             or at any time throughout the study.

          -  Participation in purely observational studies is acceptable.

          -  Infant who is a direct descendant (child, grandchild) of the study site personnel.