InfluenzaNCT02559505

Influenza Immunity in Children

A study testing Seasonal IIV 0.25 mL dose, Natural influenza infection and Seasonal IIV 0.5 mL dose in people with Influenza, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 3 months to 8 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Seasonal IIV 0.25 mL dose, Natural influenza infection and Seasonal IIV 0.5 mL dose
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 1 siteUnited States
Study dates: Oct 2015to 3 Jul 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 months to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester
Rochester, New York, 14642

Other trials in United States

About this study

Official title: Understanding How the Initial Encounter With Influenza Virus Poises Children for Protective Immunity

Read the 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.

Conditions: Influenza
Being tested: Seasonal IIV 0.25 mL dose, Natural influenza infection, Seasonal IIV 0.5 mL dose
Keywords: natural influenza infection, live attenuated influenza vaccination (LAIV), inactivated influenza vaccination (IIV), infants, children
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Seasonal IIV 0.25 mL doseBiological
Also called Inactivated influenza vaccine
Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age
Natural influenza infectionOther
Children enrolled on presentation to their primary care provider with a natural influenza infection
Seasonal IIV 0.5 mL doseBiological
Also called inactivated influenza vaccine
Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age

Study groups in NCT02559505
Study group	Role	What they receive
6-12 months Seasonal IIV	Experimental	Children 6 - 12 months of age vaccinated with seasonal IIV Receives: Biological: Seasonal IIV 0.25 mL dose
3-12 months natural infection	Experimental	Children 3-12 months of age presenting with natural influenza infection Receives: Other: Natural influenza infection; Biological: Seasonal IIV 0.5 mL dose
13-35 months Seasonal IIV	Experimental	Children 13-35 months of age vaccinated with seasonal IIV Receives: Biological: Seasonal IIV 0.25 mL dose
13-35 months natural infection	Experimental	Children 13-35 months of age presenting with natural influenza infection Receives: Other: Natural influenza infection; Biological: Seasonal IIV 0.5 mL dose
3-5 years Seasonal IIV	Experimental	Children 3-5 years of age vaccinated with seasonal IIV Receives: Biological: Seasonal IIV 0.5 mL dose
3-5 years natural infection	Experimental	Children 3-5 years of age presenting with natural influenza infection Receives: Other: Natural influenza infection; Biological: Seasonal IIV 0.5 mL dose
6-8 years Seasonal IIV	Experimental	Children 6-8 years of age vaccinated with seasonal IIV Receives: Biological: Seasonal IIV 0.5 mL dose
6-8 years natural infection	Experimental	Children 6-8 years of age presenting with natural influenza infection Receives: Other: Natural influenza infection; Biological: Seasonal IIV 0.5 mL dose

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Visit 2 (day 8-14 post enrollment)
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
Measured: Visit 3 (day 20-28 post enrollment)
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
Measured: Visit 4 (day of vaccination year 2)
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
Measured: Visit 5 (day 8-14 post-vaccination year 2)
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
Measured: Visit 6 (day 20-28 post-vaccination year 2)

Secondary outcomes (2)

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.
Measured: Baseline to day 24 study year 1
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.
Measured: Baseline to day 24 study year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 20153 Jul 2020

First posted24 Sep 2015 (estimated)
Study startOct 2015
Primary completion3 Jul 2020
Study completion3 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02559505
Sponsor's protocol ID: RSRB00058437
Status last verified: Aug 2021
First submitted: 18 Sep 2015
Last updated: 2 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Shannon I, White CL, Yang H, Nayak JL. Differences in Influenza-Specific CD4 T-Cell Mediated Immunity Following Acute Infection Versus Inactivated Vaccination in Children. J Infect Dis. 2021 Jun 15;223(12):2164-2173. doi: 10.1093/infdis/jiaa664.
PubMed 33074330

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Post Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Understanding How the Initial Encounter With Influenza Virus Poises Children for Protective Immunity
ClinicalTrials.gov ID: NCT02559505
Acronym / sponsor ID: RSRB00058437
Conditions: Influenza
Keywords: natural influenza infection, live attenuated influenza vaccination (LAIV), inactivated influenza vaccination (IIV), infants, children
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Study start: Oct 2015 (actual)
Primary completion: 3 Jul 2020 (actual)
Study completion: 3 Jul 2020 (actual)
First posted: 24 Sep 2015 (estimated)
Results: Posted 2 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
6-12 months Seasonal IIV	Experimental	Biological: Seasonal IIV 0.25 mL doseChildren 6 - 12 months of age vaccinated with seasonal IIV
3-12 months natural infection	Experimental	Other: Natural influenza infection, Biological: Seasonal IIV 0.5 mL doseChildren 3-12 months of age presenting with natural influenza infection
13-35 months Seasonal IIV	Experimental	Biological: Seasonal IIV 0.25 mL doseChildren 13-35 months of age vaccinated with seasonal IIV
13-35 months natural infection	Experimental	Other: Natural influenza infection, Biological: Seasonal IIV 0.5 mL doseChildren 13-35 months of age presenting with natural influenza infection
3-5 years Seasonal IIV	Experimental	Biological: Seasonal IIV 0.5 mL doseChildren 3-5 years of age vaccinated with seasonal IIV
3-5 years natural infection	Experimental	Other: Natural influenza infection, Biological: Seasonal IIV 0.5 mL doseChildren 3-5 years of age presenting with natural influenza infection
6-8 years Seasonal IIV	Experimental	Biological: Seasonal IIV 0.5 mL doseChildren 6-8 years of age vaccinated with seasonal IIV
6-8 years natural infection	Experimental	Other: Natural influenza infection, Biological: Seasonal IIV 0.5 mL doseChildren 6-8 years of age presenting with natural influenza infection

Who may qualify

Ages: 3 months to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (11 listed)

Age
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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Seasonal IIV 0.25 mL doseAlso: Inactivated influenza vaccineFluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age	Biological	13-35 months Seasonal IIV, 6-12 months Seasonal IIV
Natural influenza infectionChildren enrolled on presentation to their primary care provider with a natural influenza infection	Other	13-35 months natural infection, 3-12 months natural infection, 3-5 years natural infection, 6-8 years natural infection
Seasonal IIV 0.5 mL doseAlso: inactivated influenza vaccineFluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age	Biological	13-35 months natural infection, 3-12 months natural infection, 3-5 years Seasonal IIV, 3-5 years natural infection, 6-8 years Seasonal IIV, 6-8 years natural infection

Primary outcome

Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects
Time frame: Visit 2 (day 8-14 post enrollment)
% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining
Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects
Time frame: Visit 3 (day 20-28 post enrollment)
% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining
Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects
Time frame: Visit 4 (day of vaccination year 2)
% H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining
Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects
Time frame: Visit 5 (day 8-14 post-vaccination year 2)
% H3 protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining
Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects
Time frame: Visit 6 (day 20-28 post-vaccination year 2)
% H3 Protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining

2 secondary outcomes

Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets
Time frame: Baseline to day 24 study year 1
Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets
Time frame: Baseline to day 24 study year 2

Results and safety

Results posted to the registry on 2 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acute	49	22
Vaccinated	84	62

Primary outcome: Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects

Time frame: Visit 2 (day 8-14 post enrollment). Mean (Standard Deviation). Unit: percentage of T cells

Measure	Acute Infected n = 16	Vaccinated n = 28
Nucleoprotein	.010 (0.0023)	0.003 (0.0018)
H3 protein	0.009 (0.0019)	0.002 (0.0015)

Acute Infected vs Vaccinated: p = 0.005, ANCOVA
Acute Infected vs Vaccinated: p = 0.024, ANCOVA

Population analysed: 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.

Primary outcome: Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects

Time frame: Visit 3 (day 20-28 post enrollment). Mean (Standard Deviation). Unit: Percentage of T cells

Measure	Acute Infected n = 16	Vaccinated n = 28
Nucleoprotein	0.012 (0.0025)	0.003 (0.0017)
H3 Protein	0.006 (0.0021)	0.004 (0.0014)

Acute Infected vs Vaccinated: p = 0.408, ANCOVA
Acute Infected vs Vaccinated: p = 0.004, ANCOVA

Primary outcome: Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects

Time frame: Visit 4 (day of vaccination year 2). Mean (Standard Deviation). Unit: Percentage of T cells

Measure	Acute Infected n = 16	Vaccinated n = 28
Nucleoprotein	0.003 (0.0030)	0.003 (0.0018)
H3 Protein	0.007 (0.0022)	0.003 (0.0015)

Acute Infected vs Vaccinated: p = 0.991, ANCOVA
Acute Infected vs Vaccinated: p = 0.334, ANCOVA

Primary outcome: Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects

Time frame: Visit 5 (day 8-14 post-vaccination year 2). Mean (Standard Deviation). Unit: Percentage of T cells

Measure	Acute Infected n = 16	Vaccinated n = 28
Nucleoprotein	0.010 (0.0031)	0.003 (0.0018)
H3 Protein	0.008 (0.0026)	0.004 (0.0015)

Acute Infected vs Vaccinated: p = 0.226, ANCOVA
Acute Infected vs Vaccinated: p = 0.036, ANCOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
6-12 Months: Vaccinated	0 of 13 (0%)	0 of 13 (0%)	0 of 13
3-12 Months: Acute	0 of 8 (0%)	0 of 8 (0%)	0 of 8
13-35 Months: Vaccinated	0 of 30 (0%)	0 of 30 (0%)	0 of 30
13-35 Months: Acute	0 of 19 (0%)	0 of 19 (0%)	0 of 19
3-5 Years: Vaccinated	0 of 18 (0%)	0 of 18 (0%)	0 of 18
3-5 Years: Acute	0 of 12 (0%)	0 of 12 (0%)	0 of 12
6-8 Years: Vaccinated	0 of 23 (0%)	0 of 23 (0%)	0 of 23
6-8 Years: Acute	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33074330Shannon I, White CL, Yang H, Nayak JL. Differences in Influenza-Specific CD4 T-Cell Mediated Immunity Following Acute Infection Versus Inactivated Vaccination in Children. J Infect Dis. 2021 Jun 15;223(12):2164-2173. doi: 10.1093/infdis/jiaa664.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer L Nayak, MD principal investigator

University of Rochester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Seasonal IIV 0.25 mL dose, Natural influenza infection and Seasonal IIV 0.5 mL dose in people with Influenza, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects (time frame: Visit 2 (day 8-14 post enrollment)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02559505, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.