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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
166
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.)
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.)
General Academic Pediatrics
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Department of Family Medicine
Pittsburgh, Pennsylvania, United States
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.
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
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.
Time frame: 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
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
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