InfluenzaPhase 4NCT03673345
Development of Childhood Anti-Influenza Immunity
A Phase 4 study testing Influenza Virus Quadrivalent Inactivated Vaccine in people with Influenza and Influenza Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study is a prospective surveillance of the immune response to seasonal vaccination in healthy children. The study will enroll a total of approximately 220 subjects. 140 children will be vaccinated with inactivated influenza vaccine (IIV) and will be divided into 4 age cohorts: 20 children between 6-12 months of… Read more about this study
- Who is it for?
- Ages 3 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza Immunisation
- What is being tested?
- Influenza Virus Quadrivalent Inactivated Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2018to 22 Dec 2020
- Phase
- Phase 4
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age:
- Between 6 and 12 months at the time of enrollment to participate in the vaccination arm of age cohort 1A
- Between 3 and 12 months at the time of enrollment to participate in the natural infection arm of age cohort 1B
- > 12 months, birth date after 2009 for either the vaccination (A) or natural infection (B) arm of age cohort 2
- Birth date between 2006 and 2009 for either the vaccination (A) or natural infection (B) arm of age cohort 3
- Birth date between 2003 and 2006 for the vaccination (A) or natural infection (B) arm of age cohort 4
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- Gestational age of = / > 37 weeks at birth
- Parent/Legally Authorized Representative (LAR) can provide informed consent, with children = / > 8 years of age providing informed assent
- Available for the duration of the study
- History of previous primary inactivated influenza vaccine (IIV) vaccination (at least 2 previous doses for age < 9 yrs, at least 1 previous dose for age 9 and older) only for participation in the vaccination (A) arm of age cohorts 2, 3, or 4
- Acute illness documented by rapid influenza test, polymerase chain reaction (PCR) testing, or testing done by either University of Rochester Medical Center (URMC) Labs or Rochester General Hospital (RGH) Clinical Microbiology Labs to be due to influenza virus only for participation in the natural infection arms (B) of age cohorts 1-4
- Children enrolled in the cohort A (vaccination cohort) are required to have an appropriate weight and vital signs as determined by a licensed medical provider. Children enrolled in the cohort B (natural infection cohort) are required to have an appropriate weight and clinically stable vital signs as determined by a licensed medical provider* *Children will not qualify for study participation if their weight is more than 2.5 standard deviations below population norms. This will be determined through calculation of a Z score using the PediTools website (https://www.peditools.org/) utilizing the appropriate Centers for Disease Control and Prevention (CDC) growth calculators for age
Who cannot join
- Immunosuppression as a result of an underlying illness or condition (including the human immunodeficiency virus (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 corticosteroid therapy
- A diagnosis of asthma requiring chronic inhaled corticosteriod use
- Participation in any clinical research study evaluating an investigational drug or therapy that is inconsistent with current standard of care within two (2) months of enrollment in this study
- Previous administration of influenza vaccine in the current influenza season only for subjects in the vaccination arm (A) of the study (subjects presenting with acute influenza infection with vaccine failure will be eligible to enroll in the B cohorts)
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- Receipt of immunoglobulin or another blood product within the year prior to study enrollment
- An acute illness within the previous 3 days or temperature > 38 degrees Celsius on screening except for participation in the natural infection (B) cohorts.
- A contraindication to influenza vaccination except infants between 3 and 5 months presenting with natural influenza infection whose only contraindication is their current age.
- Anemia in the previous 6 months (children on iron supplementation with no documentation of abnormal hemoglobin and/or hematocrit for >6 months will be allowed to participate in the study)
- Recent (within 120 days) hospitalization, excluding hospitalization for delivery or subjects enrolled in the acute cohort who have been hospitalized for influenza-related reasons
- Any medical history or other condition that the study Principal Investigator (PI) feels may have a more than a minimal impact on the immune response or may impact safety of the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, 14642-0001
About this study
Official title: Effect of Influenza Vaccination or Infection on the Development of Protective Immunity in Children
This study is a prospective surveillance of the immune response to seasonal vaccination in healthy children. The study will enroll a total of approximately 220 subjects. 140 children will be vaccinated with inactivated influenza vaccine (IIV) and will be divided into 4 age cohorts: 20 children between 6-12 months of age, 60 children greater than 12 months of age and born after 2009, 30 children with a birth date between 2006 and 2009, and 30 children with a birth date between 2003 and 2006. 80 children presenting with natural influenza infection prior to receipt of influenza vaccination also will be divided into 4 age cohorts: 20 children between 3-12 months of age, 20 children greater than 12 months of age with a birth date after 2009, 20 children with a birth date between 2006 and 2009, and 20 children with a birth date between 2003 and 2006. Influenza vaccines will be administered using age-appropriate guidelines in all years of the study: Fluzone 0.25 mL administered intramuscularly to children between 6 and 35 months of age and 0.5 mL to children 36 months of age and older. Subjects will be seen at one domestic site and their participation duration is 2 influenza seasons plus 1 optional season. The primary hypothesis being tested in this study is that there will be differences in the specificity, magnitude and functionality of CD4 T cell and B cell reactivity in a cohort of children depending on early childhood exposures. The primary objective of this study is to evaluate the relationship between influenza virus exposure, infection and vaccine history, and CD4 T cell reactivity in a cohort of children with well documented influenza exposures.
Read the detailed description
This study is a prospective surveillance of the immune response to seasonal vaccination in healthy children. The study will enroll a total of approximately 220 subjects. 140 children will be vaccinated with inactivated influenza vaccine (IIV) and will be divided into 4 age cohorts: 20 children between 6-12 months of age, 60 children greater than 12 months of age and born after 2009, 30 children with a birth date between 2006 and 2009, and 30 children with a birth date between 2003 and 2006. 80 children presenting with natural influenza infection prior to receipt of influenza vaccination also will be divided into 4 age cohorts: 20 children between 3-12 months of age, 20 children greater than 12 months of age with a birth date after 2009, 20 children with a birth date between 2006 and 2009, and 20 children with a birth date between 2003 and 2006. Influenza vaccines will be administered using age-appropriate guidelines in all years of the study: Fluzone 0.25 mL administered intramuscularly to children between 6 and 35 months of age and 0.5 mL to children 36 months of age and older. Subjects will be seen at one domestic site and their participation duration is 2 influenza seasons plus 1 optional season. The primary hypothesis being tested in this study is that there will be differences in the specificity, magnitude and functionality of CD4 T cell and B cell reactivity in a cohort of children depending on early childhood exposures. The primary objective of this study is to evaluate the relationship between influenza virus exposure, infection and vaccine history, and CD4 T cell reactivity in a cohort of children with well documented influenza exposures.
- Conditions
- Influenza, Influenza Immunisation
- Being tested
- Influenza Virus Quadrivalent Inactivated Vaccine
- Keywords
- B Cell, CD4 T Cell, Children, Influenza Vaccination, Protective Immunity
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Virus Quadrivalent Inactivated VaccineBiological
A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A | Experimental | 0.25 mL dose of IIV-4 administered intramuscularly on days 0 and 28 of study year 1 and on day 0 of study year 2 in children 6-12 months of age who have not previously had an influenza infection or vaccination, n=20 Receives: Biological: Influenza Virus Quadrivalent Inactivated Vaccine |
| Cohort 1B | Experimental | 0.25 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 after primary influenza infection in study year 1 in children 3-12 months of age, who have not previously had an influenza vaccination, n=20 Receives: Biological: Influenza Virus Quadrivalent Inactivated Vaccine |
| Cohort 2A | Experimental | 0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=60 Receives: Biological: Influenza Virus Quadrivalent Inactivated Vaccine |
| Cohort 2B | Experimental | 0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20 Receives: Biological: Influenza Virus Quadrivalent Inactivated Vaccine |
| Cohort 3A | Experimental | 0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2006 and 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=30 Receives: Biological: Influenza Virus Quadrivalent Inactivated Vaccine |
| Cohort 3B | Experimental | 0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2006 and 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20 Receives: Biological: Influenza Virus Quadrivalent Inactivated Vaccine |
| Cohort 4A | Experimental | 0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2003 and 2006, who have previously received 2 doses of influenza vaccine prior to the study, n=30 Receives: Biological: Influenza Virus Quadrivalent Inactivated Vaccine |
| Cohort 4B | Experimental | 0.5 mL does of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2003 and 2006, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20 Receives: Biological: Influenza Virus Quadrivalent Inactivated Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of CD4 T Cells With a Given Functional Potential
Percent of ICOS/PD1+ expressing cells within CXCR5+ CD4 T cell population
Measured: Year 2 (Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start25 Sep 2018
- Primary completion22 Dec 2020
- Study completion22 Dec 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.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673345
- Sponsor's protocol ID
- 18-0009
- Other IDs
- HHSN272201400005C
- Status last verified
- 29 Mar 2021
- First submitted
- 30 Aug 2018
- Last updated
- 18 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Influenza Vaccination or Infection on the Development of Protective Immunity in Children
- ClinicalTrials.gov ID
- NCT03673345
- Acronym / sponsor ID
- 18-0009
- Conditions
- Influenza, Influenza Immunisation
- Keywords
- B Cell, CD4 T Cell, Children, Influenza Vaccination, Protective Immunity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Posted 18 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective surveillance of the immune response to seasonal vaccination in healthy children. The study will enroll a total of approximately 220 subjects. 140 children will be vaccinated with inactivated influenza vaccine (IIV) and will be divided into 4 age cohorts: 20 children between 6-12 months of age, 60 children greater than 12 months of age and born after 2009, 30 children with a birth date between 2006 and 2009, and 30 children with a birth date between 2003 and 2006. 80 children presenting with natural influenza infection prior to receipt of influenza vaccination also will be divided into 4 age cohorts: 20 children between 3-12 months of age, 20 children greater than 12 months of age with a birth date after 2009, 20 children with a birth date between 2006 and 2009, and 20 children with a birth date between 2003 and 2006. Influenza vaccines will be administered using age-appropriate guidelines in all years of the study: Fluzone 0.25 mL administered intramuscularly to children between 6 and 35 months of age and 0.5 mL to children 36 months of age and older. Subjects will be seen at one domestic site and their participation duration is 2 influenza seasons plus 1 optional season. The primary hypothesis being tested in this study is that there will be differences in the specificity, magnitude and functionality of CD4 T cell and B cell reactivity in a cohort of children depending on early childhood exposures. The primary objective of this study is to evaluate the relationship between influenza virus exposure, infection and vaccine history, and CD4 T cell reactivity in a cohort of children with well documented influenza exposures.
Detailed description
This study is a prospective surveillance of the immune response to seasonal vaccination in healthy children. The study will enroll a total of approximately 220 subjects. 140 children will be vaccinated with inactivated influenza vaccine (IIV) and will be divided into 4 age cohorts: 20 children between 6-12 months of age, 60 children greater than 12 months of age and born after 2009, 30 children with a birth date between 2006 and 2009, and 30 children with a birth date between 2003 and 2006. 80 children presenting with natural influenza infection prior to receipt of influenza vaccination also will be divided into 4 age cohorts: 20 children between 3-12 months of age, 20 children greater than 12 months of age with a birth date after 2009, 20 children with a birth date between 2006 and 2009, and 20 children with a birth date between 2003 and 2006. Influenza vaccines will be administered using age-appropriate guidelines in all years of the study: Fluzone 0.25 mL administered intramuscularly to children between 6 and 35 months of age and 0.5 mL to children 36 months of age and older. Subjects will be seen at one domestic site and their participation duration is 2 influenza seasons plus 1 optional season. The primary hypothesis being tested in this study is that there will be differences in the specificity, magnitude and functionality of CD4 T cell and B cell reactivity in a cohort of children depending on early childhood exposures. The primary objective of this study is to evaluate the relationship between influenza virus exposure, infection and vaccine history, and CD4 T cell reactivity in a cohort of children with well documented influenza exposures.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A | Experimental | Biological: Influenza Virus Quadrivalent Inactivated Vaccine0.25 mL dose of IIV-4 administered intramuscularly on days 0 and 28 of study year 1 and on day 0 of study year 2 in children 6-12 months of age who have not previously had an influenza infection or vaccination, n=20 |
| Cohort 1B | Experimental | Biological: Influenza Virus Quadrivalent Inactivated Vaccine0.25 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 after primary influenza infection in study year 1 in children 3-12 months of age, who have not previously had an influenza vaccination, n=20 |
| Cohort 2A | Experimental | Biological: Influenza Virus Quadrivalent Inactivated Vaccine0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=60 |
| Cohort 2B | Experimental | Biological: Influenza Virus Quadrivalent Inactivated Vaccine0.25 mL (less than 36 months of age) or 0.5 mL (36 months of age or older) dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children greater than 12 months of age and born after 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20 |
| Cohort 3A | Experimental | Biological: Influenza Virus Quadrivalent Inactivated Vaccine0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2006 and 2009, who have previously received 2 doses of influenza vaccine prior to the study, n=30 |
| Cohort 3B | Experimental | Biological: Influenza Virus Quadrivalent Inactivated Vaccine0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2006 and 2009, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20 |
| Cohort 4A | Experimental | Biological: Influenza Virus Quadrivalent Inactivated Vaccine0.5 mL dose of IIV-4 administered intramuscularly on day 0 of study year 1 and day 0 of study year 2 in children born between 2003 and 2006, who have previously received 2 doses of influenza vaccine prior to the study, n=30 |
| Cohort 4B | Experimental | Biological: Influenza Virus Quadrivalent Inactivated Vaccine0.5 mL does of IIV-4 administered intramuscularly on day 0 of study year 2 in children born between 2003 and 2006, who have previously had an influenza infection in study year 1 and have received 2 doses of influenza vaccine prior to the study, n=20 |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Age:
- Gestational age of = / > 37 weeks at birth
- Parent/Legally Authorized Representative (LAR) can provide informed consent, with children = / > 8 years of age providing informed assent
- Available for the duration of the study
- History of previous primary inactivated influenza vaccine (IIV) vaccination (at least 2 previous doses for age < 9 yrs, at least 1 previous dose for age 9 and older) only for participation in the vaccination (A) arm of age cohorts 2, 3, or 4
Key exclusion criteria (12 listed)
- Immunosuppression as a result of an underlying illness or condition (including the human immunodeficiency virus (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 corticosteroid therapy
- A diagnosis of asthma requiring chronic inhaled corticosteriod use
- Participation in any clinical research study evaluating an investigational drug or therapy that is inconsistent with current standard of care within two (2) months of enrollment in this study
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 |
|---|---|---|
| Influenza Virus Quadrivalent Inactivated VaccineA seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage). | Biological | Cohort 1A, Cohort 1B, Cohort 2A, Cohort 2B, Cohort 3A, Cohort 3B, Cohort 4A, Cohort 4B |
Primary outcome
Frequency of CD4 T Cells With a Given Functional Potential
Time frame: Year 2 (Visit 5)
Percent of ICOS/PD1+ expressing cells within CXCR5+ CD4 T cell population
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza Virus Quadrivalent Inactivated Vaccine in people with Influenza and Influenza Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 12 inclusion and 12 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 18 Mar 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2022). 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?
Frequency of CD4 T Cells With a Given Functional Potential (time frame: Year 2 (Visit 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2022.