Clinical trial NCT03982069: Immunologic Response to FluMist vs. Flucelvax
Official title: Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Immune Response
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2019-06-11
Enrollment: 465
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 4-21 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.

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

Primary outcomes:
measure: Number of Participants With Seroconversion Response In 2019
timeFrame: Post-vaccination (at Day 28 timepoint)
measure: Number of Participants With Seroconversion Response In 2020
timeFrame: Post-vaccination (at Day 28 timepoint)
Secondary outcomes:
measure: Number of Participants With Seroprotection Response in 2019
timeFrame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
measure: Geometric Mean Titers (GMTs) at Each Time Point 2019
timeFrame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
measure: Number of Participants With Seroprotection Response in 2020
timeFrame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
measure: Geometric Mean Titers (GMTs) at Each Time Point 2020
timeFrame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 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: