Immunologic Response to Influenza Vaccination in Children and Adolescents

Immunologic Response to Influenza Vaccination in Children and Adolescents: A RCT Trial of Influenza Vaccines

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).

Study Overview

• Status: Completed
• Conditions: Immune Response; Influenza, Human
• Intervention / Treatment: Biological: Flucelvax inactivated influenza vaccine; Biological: Fluzone inactivated influenza vaccine

Detailed Description

This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-20 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 Type: Interventional
• Enrollment (Actual): 166
• 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 20 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
ACTIVE_COMPARATOR: Fluzone inactivated influenza vaccine; Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly	Biological: Fluzone inactivated influenza vaccine; Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination	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.	Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining Seroprotection Level at Each Time Point	Hemagglutination inhibition assay will be 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 21 timepoint)
Determining Geometric Mean Titers (GMTs) at Each Time Point	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 21 timepoint)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2018
• Primary Completion (ACTUAL): December 13, 2018
• Study Completion (ACTUAL): December 13, 2018

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (ACTUAL): August 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: vaccine; influenza; inactivated
• 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: PRO18050091; CDCU01IP001035 (OTHER_GRANT: 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