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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01262079

Enrollment

180

Registered

2010-12-17

Start date

2010-12-31

Completion date

2011-08-31

Last updated

2011-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

influenza, healthy volunteer, immunity, antibody, blood sample

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Influenza-specific antibody responses	2010-2011 influenza season	To evaluate antibody responses to a panel of influenza strains across a broad age range of the U.S. population early as compared to late in the 2010-2011 influenza season.

Secondary

Measure	Time frame	Description
Influenza-specific T-cell responses	2010-2011 influenza season	To evaluate influenza-specific T-cell responses to a panel of influenza strains across a broad age range of the U.S. population early as compared to late in the 2010-2011 influenza season.

Countries

United States

Outcome results