Clinical trial NCT03614975: Immunologic Response to Influenza Vaccination in Children and Adolescents
Official title: Immunologic Response to Influenza Vaccination in Children and Adolescents: A RCT Trial of Influenza Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Immune Response
Keywords: inactivated
influenza
vaccine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2018-08-03
Enrollment: 166
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination
timeFrame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
Secondary outcomes:
measure: Determining Seroprotection Level at Each Time Point
timeFrame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
measure: Determining Geometric Mean Titers (GMTs) at Each Time Point
timeFrame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: General Academic Pediatrics
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Department of Family Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, School of Medicine, Dept. Family Medicine
name: Richard K Zimmerman, MD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moehling KK, Zimmerman RK, Nowalk MP, Jeng Lin C, Martin JM, Alcorn JF, Susick M, Burroughs A, Holiday C, Flannery B, Levine MZ. A randomized controlled trial of antibody response to 2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine in children. Vaccine. 2020 Jul 14;38(33):5171-5177. doi: 10.1016/j.vaccine.2020.06.023. Epub 2020 Jun 21.