Influenza
Conditions
Keywords
natural influenza infection, live attenuated influenza vaccination (LAIV), inactivated influenza vaccination (IIV), infants, children
Brief 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.
Detailed description
The proposed research addresses the fact that, despite high childhood morbidity from influenza and broad recommendations for vaccination, very little is known about how anti-influenza immunity is shaped by the method of initial exposure. The objective of this research is to understand how CD4 T cell and B cell responses are altered by the method of initial influenza priming, with the long-term goal of determining how a child's initial influenza encounter poises the immune system to respond to subsequent influenza challenges. The investigators central hypothesis is that differences in the mode of influenza antigen exposure in early childhood will generate long lasting, detectable changes in memory CD4 T cell and B cell specificity and function that influence the response to future influenza vaccinations and infections. This hypothesis will be tested by comparing 1) CD4 T cell and 2) antibody responses in cohorts of children initially exposed to influenza through either natural infection or inactivated or live attenuated vaccination. A combination of multiparameter assays will be used to determine the phenotype and functional potential of hemagglutinin (HA)- and nucleoprotein (NP)-specific CD4 T cells. The breadth and avidity of the neutralizing and non-neutralizing antibody responses and its distribution against head and stalk epitopes will also be evaluated. By determining how initial priming shapes the specificity and functional potential of the anti-influenza CD4 T cell and antibody responses, the investigators will gain the knowledge necessary to optimize current influenza vaccination strategies and develop novel influenza vaccines able to provide highly efficacious universal protection against both seasonal and potentially pandemic viral strains.
Interventions
BIOLOGICALSeasonal IIV 0.25 mL dose
Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age
OTHERNatural influenza infection
Children enrolled on presentation to their primary care provider with a natural influenza infection
BIOLOGICALSeasonal IIV 0.5 mL dose
Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age
Sponsors
University of Rochester
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 8 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | Visit 2 (day 8-14 post enrollment) | % H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | Baseline to day 24 study year 1 | CD4 T cell quantity and specificity will be measured using intracellular cytokine staining. We report here the mean change in percent of cells reactive to the influenza HA protein and H3 protein. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 10 and Day 24 in PBMC Gene Expression | Days 10 and 24 post vaccination | Changes in PBMC gene expression patterns due to prior influenza exposure will be assessed using RNA-seq analysis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 6-12 Months of Age: Vaccinated Children 6 - 12 months of age vaccinated with seasonal IIV
Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 13 |
| 3-12 Months of Age: Acute Children 3-12 months of age presenting with natural influenza infection
Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection
Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 8 |
| 13-35 Months of Age: Vaccinated Children 13-35 months of age vaccinated with seasonal IIV
Seasonal IIV 0.25 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 30 |
| 13-35 Months of Age: Acute Children 13-35 months of age presenting with natural influenza infection
Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection
Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 19 |
| 3-5 Years of Age: Vaccinated Children 3-5 years of age vaccinated with seasonal IIV
Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 18 |
| 3-5 Years of Age: Acute Children 3-5 years of age presenting with natural influenza infection
Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection
Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 12 |
| 6-8 Years of Age: Vaccinated Children 6-8 years of age vaccinated with seasonal IIV
Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 23 |
| 6-8 Years of Age: Acute Children 6-8 years of age presenting with natural influenza infection
Natural influenza infection: Children enrolled on presentation to their primary care provider with a natural influenza infection
Seasonal IIV 0.5 mL dose: Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age | 9 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 23 | 20 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | 6-12 Months of Age: Vaccinated | Total | 6-8 Years of Age: Acute | 6-8 Years of Age: Vaccinated | 3-5 Years of Age: Acute | 3-5 Years of Age: Vaccinated | 13-35 Months of Age: Acute | 13-35 Months of Age: Vaccinated | 3-12 Months of Age: Acute |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 13 participants | 132 participants | 9 participants | 23 participants | 12 participants | 18 participants | 19 participants | 30 participants | 8 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 15 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 4 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 117 Participants | 6 Participants | 23 Participants | 10 Participants | 18 Participants | 15 Participants | 27 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 39 Participants | 5 Participants | 1 Participants | 3 Participants | 0 Participants | 11 Participants | 12 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 25 Participants | 1 Participants | 7 Participants | 0 Participants | 4 Participants | 3 Participants | 7 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 62 Participants | 2 Participants | 15 Participants | 8 Participants | 14 Participants | 3 Participants | 10 Participants | 4 Participants |
| Region of Enrollment United States | 13 participants | 132 participants | 9 participants | 23 participants | 12 participants | 18 participants | 19 participants | 30 participants | 8 participants |
| Sex: Female, Male Female | 9 Participants | 64 Participants | 6 Participants | 10 Participants | 6 Participants | 8 Participants | 8 Participants | 14 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 68 Participants | 3 Participants | 13 Participants | 6 Participants | 10 Participants | 11 Participants | 16 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 8 | 0 / 30 | 0 / 19 | 0 / 18 | 0 / 12 | 0 / 23 | 0 / 9 |
| other Total, other adverse events | 0 / 13 | 0 / 8 | 0 / 30 | 0 / 19 | 0 / 18 | 0 / 12 | 0 / 23 | 0 / 9 |
| serious Total, serious adverse events | 0 / 13 | 0 / 8 | 0 / 30 | 0 / 19 | 0 / 18 | 0 / 12 | 0 / 23 | 0 / 9 |
Outcome results
Primary
Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects
% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining
Time frame: Visit 2 (day 8-14 post enrollment)
Population: 6 acute participants were infected with influenza strains that were not H3 and therefore were not included in the data analyzed for the primary outcome. Only vaccinated participants that age matched to the acute subjects were analyzed, resulting in 16 acutely infected and 28 vaccinated subjects included in the data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Infected | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | Nucleoprotein | .010 percentage of T cells | Standard Deviation 0.0023 |
| Acute Infected | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | H3 protein | 0.009 percentage of T cells | Standard Deviation 0.0019 |
| Vaccinated | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | Nucleoprotein | 0.003 percentage of T cells | Standard Deviation 0.0018 |
| Vaccinated | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | H3 protein | 0.002 percentage of T cells | Standard Deviation 0.0015 |
p-value: 0.005ANCOVA
p-value: 0.024ANCOVA
Primary
Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects
% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining
Time frame: Visit 3 (day 20-28 post enrollment)
Population: 6 acute participants were infected with influenza strains that were not H3 and therefore were not included in the data analyzed for the primary outcome. Only vaccinated participants that age matched to the acute subjects were analyzed, resulting in 16 acutely infected and 28 vaccinated subjects included in the data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Infected | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | Nucleoprotein | 0.012 Percentage of T cells | Standard Deviation 0.0025 |
| Acute Infected | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | H3 Protein | 0.006 Percentage of T cells | Standard Deviation 0.0021 |
| Vaccinated | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | Nucleoprotein | 0.003 Percentage of T cells | Standard Deviation 0.0017 |
| Vaccinated | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | H3 Protein | 0.004 Percentage of T cells | Standard Deviation 0.0014 |
p-value: 0.408ANCOVA
p-value: 0.004ANCOVA
Primary
Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects
% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining
Time frame: Visit 4 (day of vaccination year 2)
Population: 6 acute participants were infected with influenza strains that were not H3 and therefore were not included in the data analyzed for the primary outcome. Only vaccinated participants that age matched to the acute subjects were analyzed, resulting in 16 acutely infected and 28 vaccinated subjects included in the data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Infected | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | Nucleoprotein | 0.003 Percentage of T cells | Standard Deviation 0.003 |
| Acute Infected | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | H3 Protein | 0.007 Percentage of T cells | Standard Deviation 0.0022 |
| Vaccinated | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | Nucleoprotein | 0.003 Percentage of T cells | Standard Deviation 0.0018 |
| Vaccinated | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | H3 Protein | 0.003 Percentage of T cells | Standard Deviation 0.0015 |
p-value: 0.991ANCOVA
p-value: 0.334ANCOVA
Primary
Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects
% H3 protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining
Time frame: Visit 5 (day 8-14 post-vaccination year 2)
Population: 6 acute participants were infected with influenza strains that were not H3 and therefore were not included in the data analyzed for the primary outcome. Only vaccinated participants that age matched to the acute subjects were analyzed, resulting in 16 acutely infected and 28 vaccinated subjects included in the data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Infected | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | Nucleoprotein | 0.010 Percentage of T cells | Standard Deviation 0.0031 |
| Acute Infected | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | H3 Protein | 0.008 Percentage of T cells | Standard Deviation 0.0026 |
| Vaccinated | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | Nucleoprotein | 0.003 Percentage of T cells | Standard Deviation 0.0018 |
| Vaccinated | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | H3 Protein | 0.004 Percentage of T cells | Standard Deviation 0.0015 |
p-value: 0.226ANCOVA
p-value: 0.036ANCOVA
Primary
Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects
% H3 Protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining
Time frame: Visit 6 (day 20-28 post-vaccination year 2)
Population: 6 acute participants were infected with influenza strains that were not H3 and therefore were not included in the data analyzed for the primary outcome. Only vaccinated participants that age matched to the acute subjects were analyzed, resulting in 16 acutely infected and 28 vaccinated subjects included in the data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Infected | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | Nucleoprotein | 0.014 Percentage of T cells | Standard Deviation 0.0029 |
| Acute Infected | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | H3 Protein | 0.008 Percentage of T cells | Standard Deviation 0.0024 |
| Vaccinated | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | Nucleoprotein | 0.003 Percentage of T cells | Standard Deviation 0.0019 |
| Vaccinated | Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects | H3 Protein | 0.007 Percentage of T cells | Standard Deviation 0.0015 |
p-value: 0.68ANCOVA
p-value: 0.002ANCOVA
Secondary
Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets
CD4 T cell quantity and specificity will be measured using intracellular cytokine staining. We report here the mean change in percent of cells reactive to the influenza HA protein and H3 protein.
Time frame: Baseline to day 24 study year 1
Population: Statistical analysis was completed on all patients who attended all six clinical visits in addition to those who had 3 or more visits that had withdrawn later.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Infected | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | HAB | 0.00112 Mean Percent change | Standard Deviation 0.0029 |
| Acute Infected | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | H3 | 0.0006729 Mean Percent change | Standard Deviation 0.0017802 |
| Vaccinated | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | H3 | 0.0002589 Mean Percent change | Standard Deviation 0.005017 |
| Vaccinated | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | HAB | 0.00497 Mean Percent change | Standard Deviation 0.00966 |
| Vaccinated Age Subset (3-5 yr) | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | HAB | 0.00622 Mean Percent change | Standard Deviation 0.01098 |
| Vaccinated Age Subset (3-5 yr) | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | H3 | 0.0053456 Mean Percent change | Standard Deviation 0.0101449 |
| Vaccinated Age Subset (6-8 yr) | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | HAB | 0.01713 Mean Percent change | Standard Deviation 0.02657 |
| Vaccinated Age Subset (6-8 yr) | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | H3 | 0.001674 Mean Percent change | Standard Deviation 0.008319 |
Secondary
Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets
CD4 T cell quantity and specificity will be measured using intracellular cytokine staining. We report here the mean change in percent of cells reactive to the influenza HA protein and H3 protein.
Time frame: Baseline to day 24 study year 2
Population: Statistical analysis was completed on all patients who attended all six clinical visits in addition to those who had 3 or more visits that had withdrawn later.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Infected | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | HAB | 0.00552 Mean Percent Change | Standard Deviation 0.01436 |
| Acute Infected | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | H3 | 0.00350 Mean Percent Change | Standard Deviation 0.00372 |
| Vaccinated | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | H3 | 0.00177 Mean Percent Change | Standard Deviation 0.00371 |
| Vaccinated | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | HAB | 0.00331 Mean Percent Change | Standard Deviation 0.01216 |
| Vaccinated Age Subset (3-5 yr) | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | HAB | 0.00003 Mean Percent Change | Standard Deviation 0.01096 |
| Vaccinated Age Subset (3-5 yr) | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | H3 | 0.00188 Mean Percent Change | Standard Deviation 0.0065 |
| Vaccinated Age Subset (6-8 yr) | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | HAB | 0.005698 Mean Percent Change | Standard Deviation 0.01729 |
| Vaccinated Age Subset (6-8 yr) | Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets | H3 | -0.0017093 Mean Percent Change | Standard Deviation 0.01015 |
Other Pre-specified
Change From Baseline to Day 10 and Day 24 in PBMC Gene Expression
Changes in PBMC gene expression patterns due to prior influenza exposure will be assessed using RNA-seq analysis
Time frame: Days 10 and 24 post vaccination