The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized controlled trial (RCT), that will assess immune response in about 440 participants (about 220 per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine).
This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-21 years given one of two FDA approved and licensed influenza vaccines: FluMist (live attenuated influenza vaccine by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine). This study will enroll about 440 healthy participants, about 220 per vaccine arm. Participants will be randomized in blocks of 4 using a 1:1 allocation to receive either FluMist or Flucelvax. 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 28 (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
465
Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
General Academic Pediatrics
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Department of Family Medicine
Pittsburgh, Pennsylvania, United States
Number of Participants With Seroconversion Response In 2019
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was 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 and a final HI titer of \>=40.
Time frame: Post-vaccination (at Day 28 timepoint)
Number of Participants With Seroconversion Response In 2020
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was 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 and a final HI titer of \>=40.
Time frame: Post-vaccination (at Day 28 timepoint)
Number of Participants With Seroprotection Response in 2019
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was 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 28 timepoint)
Geometric Mean Titers (GMTs) at Each Time Point 2019
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition assay was 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 28 timepoint)
Number of Participants With Seroprotection Response in 2020
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer \>= 1:110 at either time point.
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Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Geometric Mean Titers (GMTs) at Each Time Point 2020
Rows in data tables represent different influenza antigens measured in 2020. 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 28 timepoint)