A DURATION OF IMMUNITY STUDY, TO ASSESS PERSISTENCE OF hSBA RESPONSE FOR UP TO 48 MONTHS AFTER COMPLETION OF VACCINATION WITH BIVALENT rLP2086 VACCINE

Pfizer Inc., 235 East 42nd Street, New York, NY 100170 个研究点目标入组 698 人开始时间: 2012年9月25日最近更新: 2021年12月21日

适应症

试验速览

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•Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
•1. Evidence of a personally signed and dated informed consent document 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. Completed primary Pfizer Sponsored MnB study meaning subjects who completed their originally intended number of scheduled vaccinations of rLP2086 vaccine,
•subjects who completed the blood draw following the last vaccination and subjects who completed the 6 months follow-up telephone call in the ‘primary’ study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 720
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Subjects presenting with any of the following will not be included in the study:
•1. Subjects who are investigational site staff members or or subjects who are Pfizer employees directly involved in the conduct of the trial.
•2. With the exception of the primary rLP2086 vaccine study, 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 Neisseria 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).

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