Immunologic Response to Influenza Vaccination in Children and Adolescents

Study Overview
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Brief Summary
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The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-20 years of age. This is a randomized controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine arm) pre- and post-vaccination to Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot).

Detailed Description
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This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-20 years given one of two FDA approved and licensed influenza vaccines: Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot). This study will enroll 120 healthy participants, 60 per vaccine arm. Participants will be randomized using a 1:1 allocation to receive either Flucelvax or Fluzone. Blood work will be conducted on all participants at baseline prior to vaccine receipt and post-vaccination at Day 7 (range 6-9 days) and Day 21 (range 21-35 days). The primary objective of the study is to determine pre and post serologic,responses to each vaccine type.

Official Title
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Immunologic Response to Influenza Vaccination in Children and Adolescents: A RCT Trial of Influenza Vaccines

Conditions
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Influenza, Human, Immune Response

Intervention / Treatment
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* Biological: Flucelvax inactivated influenza vaccine
* Biological: Fluzone inactivated influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 4-20 years; has prior vaccination history available (which can be determined based either on medical record review or through state registry review; plans to receive the current seasonal influenza vaccination at one of the recruiting sites Exclusion Criteria: unable or unwilling to completed required study activities, including informed consent, randomization to vaccine, and bloodwork; has already received influenza vaccine for the current season; has a known immunocompromising condition or is on an immunosuppressing medication (e.g., high dose steroids >10 days); is known to be pregnant; has a history of severe allergy to eggs or to influenza vaccine or any of its components

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flucelvax inactivated influenza vaccine<br>Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly | Biological: Flucelvax inactivated influenza vaccine<br>* Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)<br>|
| Active Comparator: Fluzone inactivated influenza vaccine<br>Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly | Biological: Fluzone inactivated influenza vaccine<br>* Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination | Hemagglutination inhibition (HI) assay will be conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of >= 10. | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining Seroprotection Level at Each Time Point | Hemagglutination inhibition assay will be conducted to assess immunologic outcome. Seroprotection is defined as a HI titer >= 1:110 at either time point. | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) | 
| Determining Geometric Mean Titers (GMTs) at Each Time Point | Hemagglutination inhibition assay will be conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inactivated, influenza, vaccine