Immunologic Response to FluMist vs. Flucelvax

Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax

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).

Study Overview

• Status: Completed
• Conditions: Immune Response; Influenza, Human
• Intervention / Treatment: Biological: FluMist live attenuated influenza vaccine; Biological: Flucelvax 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.

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • General Academic Pediatrics
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh Department of Family Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FluMist live attenuated influenza vaccine; Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally	Biological: FluMist live attenuated influenza vaccine; Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
Active Comparator: Flucelvax inactivated influenza vaccine; Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly	Biological: Flucelvax inactivated influenza vaccine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Post-vaccination (at Day 28 timepoint)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)

Collaborators and Investigators

• Sponsor: Richard Zimmerman MD
• Collaborators: Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Actual): December 9, 2020
• Study Completion (Actual): December 9, 2020

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: STUDY19040242; 1U01|P001035-01 (Other Grant/Funding Number: Centers for Disease Control and Prevention)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the primary article, after deidentification, will be placed at the site mentioned below.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months after article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal and have appropriate data security and privacy plans in place
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No