Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose

Inclusion Criteria for Stage 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.
• Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
• 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.
• 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):

• 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.
• Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.
• Subject is confirmed as having received bivalent rLP2086 in the primary vaccination study.
• Subject has completed B1971033 Stage 1 and completed the Visit 6 blood draw.
• 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.
• Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
• 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.
• 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):

• 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.
• Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.
• 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.
• Subject must have completed booster vaccination at Visit 7.

Exclusion Criteria for Stage 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.
• 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.
• 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.
• History of culture-proven disease caused by N meningitidis or Neisseria gonorrhoeae.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate blood draw.
• Receipt of any blood products, including gamma globulin, in the period from 6 months before any study visit.
• Vaccination with any licensed or experimental meningococcal serogroup B vaccine since being enrolled in the primary Pfizer-sp