Immunologic Response to Influenza Vaccination in Children and Adolescents

Phase 4

Completed

Interventions: Biological: Flucelvax inactivated influenza vaccine
Biological: Fluzone inactivated influenza vaccine

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Flucelvax inactivated influenza vaccine	Flucelvax inactivated influenza vaccine	Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Fluzone inactivated influenza vaccine	Fluzone inactivated influenza vaccine	Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly

Primary Outcome Measures

Name	Time	Method
Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination	Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)	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.

Secondary Outcome Measures

Name	Time	Method
Determining Geometric Mean Titers (GMTs) at Each Time Point	Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)	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
Determining Seroprotection Level at Each Time Point	Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)	Hemagglutination inhibition assay will be conducted to assess immunologic outcome. Seroprotection is defined as a HI titer \>= 1:110 at either time point.

Locations (2): University of Pittsburgh Department of Family Medicine
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Pittsburgh, Pennsylvania, United States
General Academic Pediatrics
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Pittsburgh, Pennsylvania, United States