Evaluation of Influenza-Specific Immune Responses in Children and Adults During the 2010-2011 Influenza Season in the U.S.

Completed

Conditions studied: Influenza

In brief

This is a specimen collection protocol designed with the purpose of understanding the immune responses to influenza in children and adult subjects through collection of blood specimens and influenza medical history data. This protocol will allow the investigators to evaluate influenza-specific immune responses to a variety of influenza strains in a broad age range of the U.S. population early and late in the 2010-2011 influenza season. Immune responses will be evaluated using blood samples. The underlying hypothesis for this protocol is that the detailed characterization of immune responses to influenza in subjects from different age groups will further the understanding of immune responses cross-reactivity and advance development of influenza vaccines that are cross-reactive against old, new and re-emerging influenza strains.

Key facts

Study ID

NCT01262079

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

180

Starts

2010-12-01

Expected to finish

2011-08-01

Last updated by the study team

2011-08-15

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Children ages 6 through 17 years and adults 18 years of age or older
• 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

You may not qualify if…

• Known to be pregnant.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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