Duration of Immunity Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01543087
First received: February 17, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

This study is a follow-up of Pfizer studies using rLP (treatment assignment known) and investigational product (treatment assignment unknown) in which the subjects will attend up to 6 study visits for collection of a 20-mL blood sample at each visit.


Condition Intervention
Meningococcal Infection
Procedure: blood sampling
Drug: bivalent rLP2086

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A DURATION-OF-IMMUNITY STUDY TO ASSESS PERSISTENCE OF hSBA RESPONSE FOR UP TO 48 MONTHS AFTER COMPLETION OF VACCINATION WITH BIVALENT rLP2086

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 6 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 12 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 18 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 24 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 36 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the 4 primary strains at each blood draw visit. [ Time Frame: Month 48 following last vaccination in primary study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: March 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
One group of subjects Procedure: blood sampling
Blood sample collection at different time points
Drug: bivalent rLP2086

Detailed Description:

Assess longevity of immune responses following receipt of 2 or 3 doses of bivalent rLP2086. The longevity of immune responses to concomitant vaccination

  Eligibility

Ages Eligible for Study:   11 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543087

  Show 52 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01543087     History of Changes
Other Study ID Numbers: B1971033
Study First Received: February 17, 2012
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 24, 2014