EUCTR2011-005697-31-DEActive, not recruitingNot Applicable
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 sites1,200 target enrollmentStarted: March 16, 2012Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 1,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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 (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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1128
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Subjects presenting with any of the following will not be included in the study:
- •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.
Investigators
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