Immunologic Response to Influenza Vaccination in Children and Adolescents: A RCT Trial of Influenza Vaccines
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 166
- Locations
- 2
- Primary Endpoint
- Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination
Study Overview
Brief Summary
The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-20 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Flucelvax inactivated influenza vaccine
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Intervention: Flucelvax inactivated influenza vaccine (Biological)
Fluzone inactivated influenza vaccine
Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly
Intervention: Fluzone inactivated influenza vaccine (Biological)
Outcomes
Primary Outcomes
Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination
Time Frame: 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 Outcomes
- Determining Seroprotection Level at Each Time Point(Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint))
- Determining Geometric Mean Titers (GMTs) at Each Time Point(Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint))
Investigators
Richard Zimmerman MD
Professor
University of Pittsburgh