Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents

Conditions
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Immune Response to Influenza Vaccine, Influenza A Virus Infection, Influenza B Virus Infection

Intervention / Treatment
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* Biological: LAIV
* Biological: IIV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LAIV 2014-15<br>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. | Biological: LAIV<br>* 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.<br>* Other names: FluMist;|
| Other: IIV 2014-15<br>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. | Biological: IIV<br>* 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.]<br>* Other names: FluZone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza |  | Change from Baseline to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polymerase Chain Reaction (PCR) Confirmed Influenza Illness |  | Onset >13 days after vaccination and before April 1, 2015 | 
| Antibody Dependent Cellular Cytotoxicity (ADCC) Titers |  | Change from Baseline to 28 days | 
| Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG) |  | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCR confirmed Influenza A virus, PCR confirmed Influenza B virus, Immune response to influenza vaccine