Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose
Condition: Meningococcal Infection
MeSH terms: Meningococcal Infections
Intervention: blood sampling; bivalent rLP2086
Intervention description: Blood sample collection at different time points; A booster dose of bivalent rLP2086 at approximately 48 months following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series will be given at Visit 7.
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Masking: None (Open Label)
Enrollment: 698.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is to assess the longevity of immune response in adolescents for approximately 48
      months after receipt of a primary series of bivalent rLP2086 vaccination, which is then
      followed by a booster dose and an assessment of immune response for 12 or 26 months post
      booster vaccination.
    

Eligibility criteria:

        Inclusion Criteria for Stage 1:

          1. Evidence of a personally signed and dated informed consent document (ICD) indicating
             that the subject (or a legal representative) has been informed of all pertinent
             aspects of the study.

          2. Subjects who are willing and able to comply with scheduled visits, laboratory tests,
             and other study procedures.

          3. Subjects who completed a primary study and received all the scheduled injections
             within the originally planned schedule, either with bivalent rLP2086 (either 2 or 3
             doses) or with investigational product in cases where subject vaccine assignment is
             blinded at the time of consent for study B1971033.

          4. Subjects who completed the blood draw following the last vaccination and subjects who
             completed the 6-month follow-up telephone call in the primary study.

        Inclusion Criteria for Booster Stage Visits 7-10 (up to12 month post booster follow up):

          1. Evidence of a personally signed and dated ICD indicating that the subject or subject's
             parent(s)/legal guardian has been informed of all pertinent aspects for Visits 7 to 10
             of the booster stage of the study.

          2. Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion
             criteria.

          3. Subject is confirmed as having received bivalent rLP2086 in the primary vaccination
             study.

          4. Subject has completed B1971033 Stage 1 and completed the Visit 6 blood draw.

          5. Subject is available for the entire period of the booster stage and the subject or
             subject's parent(s)/legal guardian can be reached by telephone.

          6. Healthy subject as determined by medical history, physical examination, and judgment
             of the investigator.

          7. Male and female subjects of childbearing potential and at risk for pregnancy must
             agree to use a highly effective method of contraception through Visit 10 of the
             booster stage. 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. Refer to Section 4.5 for further information.

          8. Negative urine pregnancy test for all female subjects on the day of the booster dose.

        Inclusion Criteria for Booster Stage Visit11 (26 month post booster follow up):

          1. For subject participating in Visit 11, evidence of a personally signed and dated ICD
             indicating that the subject or subject's parent(s)/legal guardian has been informed of
             all pertinent aspects of Visit 11.

          2. Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion
             criteria.

          3. Subject must have received 2 or 3 doses of bivalent rLP2086 in the primary study on a
             0-, 2-, and 6-month or a 0- and 6-month schedule.

          4. Subject must have completed booster vaccination at Visit 7.

        Exclusion Criteria for Stage 1:

          1. Subjects who are investigational site staff members directly involved in the conduct
             of the trial and their family members, site staff members otherwise supervised by the
             investigator, or subjects who are Pfizer employees directly involved in the conduct of
             the trial.

          2. With the exception of the primary study of bivalent rLP2086, participation in other
             studies within the 1-month (30-day) period before study Visit 1 and/or during study
             participation. Participation in purely observational studies is permitted.

          3. Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation 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.

          4. History of culture-proven disease caused by N meningitidis or Neisseria gonorrhoeae.

          5. Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate blood draw.

          6. Receipt of any blood products, including gamma globulin, in the period from 6 months
             before any study visit.

          7. Vaccination with any licensed or experimental meningococcal serogroup B vaccine since
             being enrolled in the primary Pfizer-sponsored MnB study (other than study vaccines
             permitted in the primary study).

          8. Subjects who were not compliant with primary study eligibility criteria while enrolled
             in the primary study.

        Exclusion Criteria for Booster Stage:

          1. Subjects who are scheduled to receive 1 or more doses of a human papillomavirus (HPV)
             vaccine as part of a 3-dose series during the 28 days after the booster vaccination.

          2. A previous anaphylactic reaction to any vaccine or vaccine-related component.

          3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
             allergen immunotherapy with a licensed product and are not on stable maintenance
             doses.

          4. Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection.

          5. 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 in the
             United States with terminal complement deficiency are excluded from participation in
             this study. Please refer to the study reference manual (SRM) for additional details.

          6. Significant neurological disorder or history of seizure (excluding simple febrile
             seizure).

          7. Current chronic use of systemic antibiotics.

          8. Current participation in another investigational study. Participation in purely
             observational studies is acceptable.

          9. Received any investigational vaccines, drugs, or devices within 28 days before
             administration of the booster vaccination.

         10. Any neuroinflammatory or autoimmune condition, including, but not limited to,
             transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

         11. 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 through Visit 10 of the study.