Evaluation of Influenza-Specific Immune Responses in Children and Adults During the 2010-2011 Influenza Season in the U.S.
NCT ID: NCT01262079
Last Updated: 2011-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
180 participants
OBSERVATIONAL
2010-12-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1: 6-15 years old
No interventions assigned to this group
Group 2: 16-25 years old
No interventions assigned to this group
Group 3: 26-35 years old
No interventions assigned to this group
Group 4: 36-45 years old
No interventions assigned to this group
Group 5: 46-55 years old
No interventions assigned to this group
Group 6: 56-65 years old
No interventions assigned to this group
Group 7: 66-75 years old
No interventions assigned to this group
Group 8: 76-85 years old
No interventions assigned to this group
Group 9: > 85 years old
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
* Able and willing to complete the informed consent/assent process
* Willing to donate blood for storage and for research, at least at three study visits
* Willing to have genetic tests performed on stored blood for research purposes
Exclusion Criteria
* Medical, psychiatric, occupational or other condition that, in the judgment of the site investigator, is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
* Bleeding disorder diagnosis or any contraindications to blood drawing as assessed by the site investigator
* Immune system known to be compromised by HIV or other active infection, active cancer, or systemic immunosuppressive treatments.
* Seasonal influenza vaccine within the 12 weeks prior to enrollment.
* Another subject from the same household enrolled into the same age group.
6 Years
ALL
Yes
Sponsors
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The Emmes Company, LLC
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Vaccine Research Center, NIAID, NIH
Principal Investigators
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Barney S. Graham, M.D., Ph.D.
Role: STUDY_DIRECTOR
Chief: Clinical Trials Core
Locations
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Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States
St. Louis University - Doisy Research Center
St Louis, Missouri, United States
Cincinatti Children's Hospital Medical Center
Cincinnati, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Subbarao K, Murphy BR, Fauci AS. Development of effective vaccines against pandemic influenza. Immunity. 2006 Jan;24(1):5-9. doi: 10.1016/j.immuni.2005.12.005.
Wei CJ, Boyington JC, McTamney PM, Kong WP, Pearce MB, Xu L, Andersen H, Rao S, Tumpey TM, Yang ZY, Nabel GJ. Induction of broadly neutralizing H1N1 influenza antibodies by vaccination. Science. 2010 Aug 27;329(5995):1060-4. doi: 10.1126/science.1192517. Epub 2010 Jul 15.
Centers for Disease Control and Prevention (CDC). Serum cross-reactive antibody response to a novel influenza A (H1N1) virus after vaccination with seasonal influenza vaccine. MMWR Morb Mortal Wkly Rep. 2009 May 22;58(19):521-4.
Related Links
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Other Identifiers
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HHSN272201000049I
Identifier Type: OTHER
Identifier Source: secondary_id
VRC 700
Identifier Type: -
Identifier Source: org_study_id
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