N/A
N=133
Influenza Immunity in Children
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02559505 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects — .010; 0.003; 0.009; 0.002 percentage of T cells — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Seasonal IIV 0.25 mL dose (Biological); Natural influenza infection (Other); Seasonal IIV 0.5 mL dose (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects |
0.014; 0.003; 0.008; 0.007 | 0.680 |
| PRIMARY Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects |
0.014; 0.003; 0.008; 0.007 | 0.680 |
| PRIMARY Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects |
0.014; 0.003; 0.008; 0.007 | 0.680 |
| PRIMARY Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects |
0.014; 0.003; 0.008; 0.007 | 0.680 |
| PRIMARY Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects |
0.014; 0.003; 0.008; 0.007 | 0.680 |
| SECONDARY Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets |
0.00552; 0.00331; 0.00003; 0.005698; 0.00350; 0.00177 | — |
| SECONDARY Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets |
0.00552; 0.00331; 0.00003; 0.005698; 0.00350; 0.00177 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT02559505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.