Immune Response to Influenza VaccinePhase 4NCT02250274
Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
A Phase 4 study testing LAIV and IIV in people with Immune Response to Influenza Vaccine and Influenza A Virus Infection, run by Marshfield Clinic Research Foundation at 1 site in United States.
Trial summary
The purpose of this study is to assess the serologic and cell-mediated immune response to licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in children 5-17 years old. The effects of prior infection and or prior season vaccination will be examined. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Immune Response to Influenza Vaccine, Influenza A Virus Infection, Influenza B Virus Infection
- What is being tested?
- LAIV and IIV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Apr 2015
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 5-17 years for the duration of the study period (Sept 1, 2014-Apr 1, 2015)
- Enrolled in either the immune response study or the vaccine effectiveness study conducted at the site in the 2013-14 influenza season
- If enrolled in the vaccine effectiveness study the previous season must have either been vaccinated and infected with influenza or unvaccinated and uninfected with influenza
Who cannot join
- Children with contraindications to either the quadrivalent live attenuated influenza vaccine or to the trivalent inactivated influenza vaccine will be excluded.
- Anyone unwilling or unable to complete all required study activities including informed consent
- Subjects who already received the influenza vaccine for the 2014-15 season
Trial locations and contacts
1 site in 1 country.
United States1 site
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449
About this study
Official title: Prospective Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
The purpose of this study is to assess the serologic and cell-mediated immune response to licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in children 5-17 years old. The effects of prior infection and or prior season vaccination will be examined. Children will be followed during the influenza season to identify laboratory-confirmed influenza (i.e. vaccine failure).
Read the detailed description
All children will have baseline blood samples drawn and will then be vaccinated with licensed and approved influenza vaccines. Following the recommendation from the Advisory Committee on Immunization Practices, children 5-8 years old will preferentially receive live attenuated influenza vaccine (LAIV). Children aged 9-17 will be randomized to receive either LAIV or inactivated influenza vaccine (IIV). Children with a medical contraindication to any licensed influenza vaccine will be excluded from the study.
The children will have their blood drawn between 2 and 4 times total over the course of two months in order to test their immune response to the vaccine. Between approximately December and April, study participants will be contacted weekly to monitor for any new respiratory illnesses with cough, and if present, nasal and throat swabs will be collected to test for influenza.
- Conditions
- Immune Response to Influenza Vaccine, Influenza A Virus Infection, Influenza B Virus Infection
- Being tested
- LAIV, IIV
- Keywords
- Immune response to influenza vaccine, PCR confirmed Influenza A virus, PCR confirmed Influenza B virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAIVBiological
Also called FluMist
Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.
IIVBiological
Also called FluZone
A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]
| Study group | Role | What they receive |
|---|---|---|
| LAIV 2014-15 | Other | Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages. Receives: Biological: LAIV |
| IIV 2014-15 | Other | Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds. Receives: Biological: IIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza
Measured: Change from Baseline to 28 days
Secondary outcomes (3)
Polymerase Chain Reaction (PCR) Confirmed Influenza Illness
Measured: Onset >13 days after vaccination and before April 1, 2015
Antibody Dependent Cellular Cytotoxicity (ADCC) Titers
Measured: Change from Baseline to 28 days
Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionApr 2015
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 Immune Response to Influenza VaccineStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshfield Clinic Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Wisconsin, Madison
- Responsible party
- Principal investigator, Edward Belongia, Marshfield Clinic Research Foundation
- Investigators
- Edward A Belongia, MD, Principal investigator, Marshfield Clinic Research Foundation - Center for Clinical Epidemiology & Population Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250274
- Sponsor's protocol ID
- 5U01IP000471-04
- Status last verified
- Mar 2018
- First submitted
- 17 Sep 2014
- Last updated
- 26 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There is a plan to publish the results of the study in a manuscript but no plans to release individual level data as the results are not clinically actionable.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
- ClinicalTrials.gov ID
- NCT02250274
- Acronym / sponsor ID
- 5U01IP000471-04
- Conditions
- Immune Response to Influenza Vaccine, Influenza A Virus Infection, Influenza B Virus Infection
- Keywords
- Immune response to influenza vaccine, PCR confirmed Influenza A virus, PCR confirmed Influenza B virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Marshfield Clinic Research FoundationUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Wisconsin, Madison
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Posted 26 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the serologic and cell-mediated immune response to licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in children 5-17 years old. The effects of prior infection and or prior season vaccination will be examined. Children will be followed during the influenza season to identify laboratory-confirmed influenza (i.e. vaccine failure).
Detailed description
All children will have baseline blood samples drawn and will then be vaccinated with licensed and approved influenza vaccines. Following the recommendation from the Advisory Committee on Immunization Practices, children 5-8 years old will preferentially receive live attenuated influenza vaccine (LAIV). Children aged 9-17 will be randomized to receive either LAIV or inactivated influenza vaccine (IIV). Children with a medical contraindication to any licensed influenza vaccine will be excluded from the study.
The children will have their blood drawn between 2 and 4 times total over the course of two months in order to test their immune response to the vaccine. Between approximately December and April, study participants will be contacted weekly to monitor for any new respiratory illnesses with cough, and if present, nasal and throat swabs will be collected to test for influenza.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAIV 2014-15 | Other | Biological: LAIVWill receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages. |
| IIV 2014-15 | Other | Biological: IIVWill receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 5-17 years for the duration of the study period (Sept 1, 2014-Apr 1, 2015)
- Enrolled in either the immune response study or the vaccine effectiveness study conducted at the site in the 2013-14 influenza season
- If enrolled in the vaccine effectiveness study the previous season must have either been vaccinated and infected with influenza or unvaccinated and uninfected with influenza
Key exclusion criteria (3 listed)
- Children with contraindications to either the quadrivalent live attenuated influenza vaccine or to the trivalent inactivated influenza vaccine will be excluded.
- Anyone unwilling or unable to complete all required study activities including informed consent
- Subjects who already received the influenza vaccine for the 2014-15 season
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 |
|---|---|---|
| LAIVAlso: FluMistLicensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV. | Biological | LAIV 2014-15 |
| IIVAlso: FluZoneA modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV. [Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.] | Biological | IIV 2014-15 |
Primary outcome
Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza
Time frame: Change from Baseline to 28 days
3 secondary outcomes
Polymerase Chain Reaction (PCR) Confirmed Influenza Illness
Time frame: Onset >13 days after vaccination and before April 1, 2015
Antibody Dependent Cellular Cytotoxicity (ADCC) Titers
Time frame: Change from Baseline to 28 days
Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is a plan to publish the results of the study in a manuscript but no plans to release individual level data as the results are not clinically actionable.
Related trials for Immune Response to Influenza Vaccine
Not yet recruitingPhase 2
Vaccination Response Modulation With a Targeted Rapamycin Protocol Study
Vaccine Immune Response, Haemodialysis Patients
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.
Edward A Belongia, MD principal investigator
Marshfield Clinic Research Foundation - Center for Clinical Epidemiology & Population Health
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 LAIV and IIV in people with Immune Response to Influenza Vaccine and Influenza A Virus Infection, run by Marshfield Clinic Research Foundation 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 3 inclusion and 3 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 26 Apr 2018. 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 26 Feb 2016). 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?
Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza (time frame: Change from Baseline to 28 days). 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 26 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.