A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.
Condition: Meningococcal Vaccine; rLP2086; Repevax; N Meningitidis Serogroup B; Meningitis
MeSH terms: Meningitis
Intervention: rLP2086; Repevax; Saline; Repevax
Intervention description: 0.5 mL dose, given at 0, 2 and 6 months.; 0.5 mL dose, given at 0 months.; 0.5 mL dose, given at 0, 2 and 6 months.; 0.5 mL dose, given at 0 months.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 753.0
Sex: All
Minimum age: 11 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy adolescents

Summary:

      This study is to look at a new vaccine that might prevent meningococcal disease, and to look
      at the safety of the new vaccine as well as how it is tolerated when given together with
      Repevax. The study will be done in healthy adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of a personally signed and dated informed consent document indicating that
             the parent/legally acceptable representative and/or subject has been informed of all
             pertinent aspects of the study.

          -  Parent/legally acceptable representative and/or subjects who are willing and able to
             comply with scheduled visits, laboratory tests, and other study procedures.

          -  Male or female subject aged ≥11 and <19 years at the time of enrollment.

          -  Available for the entire study period and can be reached by telephone.

          -  Healthy subject as determined by medical history, physical examination, and judgment
             of the investigator.

          -  Has received full series of diphtheria, tetanus, and pertussis (DTP)/DTaP vaccines and
             oral poliomyelitis virus (OPV)/IPV vaccines per country-specific recommendations
             applicable at the time of receipt.

          -  All male and female subjects must agree to practice a form of effective contraception,
             such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm,
             cervical cap or intrauterine device), implants, injectables, combined oral
             contraceptives or sexual abstinence prior to entering into the study, for the duration
             of the vaccination period and for 28 days after the last study vaccination. For
             Germany: The phrase sexual abstinence is not applicable, with the understanding that
             all male and all female subjects of childbearing potential must practice an effective
             form of contraception during the study.

          -  Negative urine pregnancy test for female subjects.

        Exclusion Criteria:

          -  Previous vaccination with any meningococcal serogroup B vaccine.

          -  Vaccination with any diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine
             within 5 years of the first study vaccination.

          -  A previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis
             virus vaccine.

          -  Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection.

          -  A known or suspected disease of the immune system or those receiving immunosuppressive
             therapy.

          -  History of culture-proven disease caused by Neisseria meningitidis or Neisseria
             gonorrhoeae.

          -  Significant neurological disorder or history of seizure (excluding simple febrile
             seizure).

          -  Receipt of any blood products, including immunoglobulin within 6 months before the
             first study vaccination.

          -  Current chronic use of systemic antibiotics.

          -  Participation in other studies during study participation. Participation in purely
             observational studies is acceptable.

          -  Received any investigational drugs, vaccines or devices within 28 days before
             administration of the first study vaccination.

          -  Any neuroinflammatory or autoimmune condition, including, but not limited to,
             transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

          -  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.

          -  Subjects who are investigational site staff members or subjects who are Pfizer
             employees directly involved in the conduct of the trial.

          -  Subject is a direct descendant (eg, child, grandchild or other family member) of study
             site or Pfizer personnel.

          -  Subject is pregnant or breastfeeding.