Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Influenza, Human
- Sponsor
- Richard Zimmerman MD
- Enrollment
- 465
- Locations
- 2
- Primary Endpoint
- Number of Participants With Seroconversion Response In 2019
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Richard Zimmerman MD
Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •aged 4-21 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
Outcomes
Primary Outcomes
Number of Participants With Seroconversion Response In 2019
Time Frame: Post-vaccination (at Day 28 timepoint)
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.
Number of Participants With Seroconversion Response In 2020
Time Frame: Post-vaccination (at Day 28 timepoint)
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.
Secondary Outcomes
- Number of Participants With Seroprotection Response in 2019(Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint))
- Geometric Mean Titers (GMTs) at Each Time Point 2019(Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint))
- Geometric Mean Titers (GMTs) at Each Time Point 2020(Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint))
- Number of Participants With Seroprotection Response in 2020(Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint))