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: February 20, 2014
Last verified: February 2014
  Purpose

This study is an open label follow-up of previously conducted Pfizer studies using the final formulation and dose of rLP2086 vaccine (primary study) in which the subjects will attend up to 6 study visits for collection of a 20-mL blood sample at each of these visits.


Condition Intervention
Meningococcal Infection
Procedure: blood sampling

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 Vaccine

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 6 following last vaccination in primary study [ Time Frame: Month 6 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 12 following last vaccination in primary study [ Time Frame: Month 12 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 18 following last vaccination in primary study [ Time Frame: Month 18 following last vaccination in primary study ]
  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 24 following last vaccination in primary study [ Time Frame: Month 24 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 36 following last vaccination in primary study [ Time Frame: Month 36 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Percentage of Participants with hSBA titers ≥ lower limit of quantitation (LLOQ) at Month 48 following last vaccination in primary study [ Time Frame: Month 48 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Percentage of Participants with hSBA titers ≥1:4, ≥1:8, ≥1:16 , ≥1:32, ≥1:64,and ≥1:128 at Month 6 following last vaccination in primary study [ Time Frame: Month 6 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Percentage of Participants with hSBA titers ≥1:4, ≥1:8, ≥1:16 , ≥1:32, ≥1:64,and ≥1:128 at Month 12 following last vaccination [ Time Frame: Month 12 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Percentage of Participants with hSBA titers ≥1:4, ≥1:8, ≥1:16 , ≥1:32, ≥1:64,and ≥1:128 at Month 18 following last vaccination in primary study [ Time Frame: Month 18 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Percentage of Participants with hSBA titers ≥1:4, ≥1:8, ≥1:16 , ≥1:32, ≥1:64,and ≥1:128 at Month 24 following last vaccination [ Time Frame: Month 24 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Percentage of Participants with hSBA titers ≥1:4, ≥1:8, ≥1:16 , ≥1:32, ≥1:64,and ≥1:128 at Month 36 following last vaccination in primary study [ Time Frame: Month 36 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • Percentage of Participants with hSBA titers ≥1:4, ≥1:8, ≥1:16 , ≥1:32, ≥1:64,and ≥1:128 at Month 48 following last vaccination in primary study [ Time Frame: Month 48 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • hSBA geometric mean titers (GMTs) at Month 6 following last vaccination in primary study [ Time Frame: Month 6 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • hSBA geometric mean titers (GMTs) at Month 12 following last vaccination in primary study [ Time Frame: Month 12 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • hSBA geometric mean titers (GMTs) at Month 18 following last vaccination in primary study [ Time Frame: Month 18 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • hSBA geometric mean titers (GMTs) at Month 24 following last vaccination in primary study [ Time Frame: Month 24 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • hSBA geometric mean titers (GMTs) at Month 36 following last vaccination in primary study [ Time Frame: Month 36 following last vaccination in primary study ] [ Designated as safety issue: No ]
  • hSBA geometric mean titers (GMTs) at Month 48 following last vaccination in primary study [ Time Frame: Month 48 following last vaccination in primary study ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: March 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 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

Detailed Description:

Assess the duration of immunity post vaccination with rLP2086 in a previous study

  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 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.

Exclusion Criteria:

  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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543087

Locations
Czech Republic
Pfizer Investigational Site
Holice, Czech Republic, 53401
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 50005
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 50002
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 50004
Pfizer Investigational Site
Jindrichuv Hradec, Czech Republic, 37701
Pfizer Investigational Site
Odolena Voda, Czech Republic, 25070
Pfizer Investigational Site
Pardubice, Czech Republic, 53012
Pfizer Investigational Site
Pardubice, Czech Republic, 53002
Pfizer Investigational Site
Praha 6, Czech Republic, 16000
Pfizer Investigational Site
Praha Nusle, Czech Republic, 14000
Pfizer Investigational Site
Sezemice, Czech Republic, 53304
Denmark
Pfizer Investigational Site
Aarhus N, Denmark, 8200
Finland
Pfizer Investigational Site
Pori, Finland, 28100
Pfizer Investigational Site
Tampere, Finland, 33100
Pfizer Investigational Site
Turku, Finland, 20520
Pfizer Investigational Site
Vantaa, Finland, 01300
Germany
Pfizer Investigational Site
Bad Saulgau, Germany, 88348
Pfizer Investigational Site
Bramsche, Germany, 49565
Sweden
Pfizer Investigational Site
Eskilstuna, Sweden, 631 88
Pfizer Investigational Site
Malmo, Sweden, 21432
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: February 20, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut
Poland: The Central Register of Clinical Trials
Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on April 17, 2014