Duration of Immunity Study
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01543087
First received: February 17, 2012
Last updated: May 14, 2013
Last verified: May 2013
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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 ] [ Designated as safety issue: No ]
- 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:
- 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.
- Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
- 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:
- Subjects who are investigational site staff members or or subjects who are Pfizer employees directly involved in the conduct of the trial.
- 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.
- 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 Neisseria 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 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
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Czech Republic | |
| Pfizer Investigational Site | Recruiting |
| Holice, Czech Republic, 53401 | |
| Pfizer Investigational Site | Recruiting |
| Hradec Kralove, Czech Republic, 50002 | |
| Pfizer Investigational Site | Recruiting |
| Hradec Kralove, Czech Republic, 50004 | |
| Pfizer Investigational Site | Recruiting |
| Hradec Kralove, Czech Republic, 50005 | |
| Pfizer Investigational Site | Recruiting |
| Jindrichuv Hradec, Czech Republic, 37701 | |
| Pfizer Investigational Site | Recruiting |
| Odolena Voda, Czech Republic, 25070 | |
| Pfizer Investigational Site | Recruiting |
| Pardubice, Czech Republic, 53002 | |
| Pfizer Investigational Site | Recruiting |
| Pardubice, Czech Republic, 53012 | |
| Pfizer Investigational Site | Recruiting |
| Praha - Nusle, Czech Republic, 14000 | |
| Pfizer Investigational Site | Recruiting |
| Praha 6, Czech Republic, 16000 | |
| Pfizer Investigational Site | Recruiting |
| Sezemice, Czech Republic, 53304 | |
| Denmark | |
| Pfizer Investigational Site | Recruiting |
| Aarhus, Denmark, 8200 | |
| Finland | |
| Pfizer Investigational Site | Recruiting |
| Pori, Finland, 28100 | |
| Pfizer Investigational Site | Recruiting |
| Tampere, Finland, 33100 | |
| Pfizer Investigational Site | Recruiting |
| Turku, Finland, 20520 | |
| Pfizer Investigational Site | Recruiting |
| Vantaa, Finland, 01300 | |
| Germany | |
| Pfizer Investigational Site | Recruiting |
| Bad Saulgau, Germany, 88348 | |
| Pfizer Investigational Site | Recruiting |
| Bramsche, Germany, 49565 | |
| Sweden | |
| Pfizer Investigational Site | Recruiting |
| Eskilstuna, Sweden, 631 88 | |
| Pfizer Investigational Site | Recruiting |
| Malmo, Sweden, 205 02 | |
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: | May 14, 2013 |
| 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 May 21, 2013