Influenza Immunity in Children

Completed · Not applicable

Conditions studied: Influenza

In brief

This study evaluates how different methods of early exposure to influenza (natural infection, live attenuated influenza vaccination, inactivated influenza vaccination) initially stimulate immunity and poise the immune system to respond to a future challenge with the inactivated influenza vaccine.

Key facts

Study ID

NCT02559505

Run by

University of Rochester

People needed

134

Starts

2015-10-01

Expected to finish

2020-07-03

Last updated by the study team

2021-09-02

Who can join

Age: 0 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age
• Between 6 and 12 months to participate in the vaccination arm of cohort 1 (cohort 1A)
• Between 3 and 12 months to participate in the natural infection arm of cohort 1 (cohort 1B)
• Between 13 and 35 months of age to participate in either the vaccination or natural infection arm of cohort 2
• Between 36 months and 5 years of age to participate in either the vaccination or natural infection arm of cohort 3
• Between 6 years and 8 years of age to participate in either the vaccination or natural infection arm of cohort 4
• Gestational age of ≥37 weeks at birth
• Parent/guardian can provide informed consent
• Available for the duration of the study
• History of previous IIV administration ONLY for participation in the vaccination arm of cohorts 2, 3, or 4
• Acute illness documented to be due to influenza virus ONLY for participation in the natural infection arms of cohorts 1-4

You may not qualify if…

• Immunosuppression as a result of an underlying illness or condition (including HIV or a primary immunodeficiency syndrome)
• Active neoplastic disease
• Use of potentially immunosuppressive medications currently or within the past year (including chemotherapeutic agents) or chronic (>2 weeks) use of oral or inhaled steroid therapy
• A diagnosis of asthma requiring chronic controller medication
• Previous administration of influenza vaccine in the current influenza season ONLY for subjects receiving an influenza vaccination
• Receipt of immunoglobulin or another blood product within the year prior to study enrollment
• An acute illness within the previous 3 days or temperature >38o on screening EXCEPT for participation in the natural infection arms of cohorts 1-4
• A contraindication to influenza vaccination EXCEPT infants between 3 and 5 months presenting with natural influenza infection whose only contraindication is their current age

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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