Influenza Immunity in Children
Influenza
About this trial
This is an interventional basic science trial for Influenza focused on measuring natural influenza infection, live attenuated influenza vaccination (LAIV), inactivated influenza vaccination (IIV), infants, children
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
6-12 months Seasonal IIV
3-12 months natural infection
13-35 months Seasonal IIV
13-35 months natural infection
3-5 years Seasonal IIV
3-5 years natural infection
6-8 years Seasonal IIV
6-8 years natural infection
Children 6 - 12 months of age vaccinated with seasonal IIV
Children 3-12 months of age presenting with natural influenza infection
Children 13-35 months of age vaccinated with seasonal IIV
Children 13-35 months of age presenting with natural influenza infection
Children 3-5 years of age vaccinated with seasonal IIV
Children 3-5 years of age presenting with natural influenza infection
Children 6-8 years of age vaccinated with seasonal IIV
Children 6-8 years of age presenting with natural influenza infection