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Immunologic Response to Influenza Vaccination in Children and Adolescents

Primary Purpose

Influenza, Human, Immune Response

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Flucelvax inactivated influenza vaccine
Fluzone inactivated influenza vaccine
Sponsored by
Richard Zimmerman MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring inactivated, influenza, vaccine

Eligibility Criteria

4 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • General Academic Pediatrics
  • University of Pittsburgh Department of Family Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Flucelvax inactivated influenza vaccine

Fluzone inactivated influenza vaccine

Arm Description

Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly

Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
June 6, 2018
Last Updated
January 7, 2020
Sponsor
Richard Zimmerman MD
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03614975
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
December 13, 2018 (Actual)
Study Completion Date
December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Richard Zimmerman MD
Collaborators
Centers for Disease Control and Prevention

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Immune Response
Keywords
inactivated, influenza, vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flucelvax inactivated influenza vaccine
Arm Type
Active Comparator
Arm Description
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Arm Title
Fluzone inactivated influenza vaccine
Arm Type
Active Comparator
Arm Description
Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly
Intervention Type
Biological
Intervention Name(s)
Flucelvax inactivated influenza vaccine
Intervention Description
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.)
Intervention Type
Biological
Intervention Name(s)
Fluzone inactivated influenza vaccine
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination
Description
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.
Time Frame
Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
Secondary Outcome Measure Information:
Title
Determining Seroprotection Level at Each Time Point
Description
Hemagglutination inhibition assay will be conducted to assess immunologic outcome. Seroprotection is defined as a HI titer >= 1:110 at either time point.
Time Frame
Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
Title
Determining Geometric Mean Titers (GMTs) at Each Time Point
Description
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
Time Frame
Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard K Zimmerman, MD, MPH, MA
Organizational Affiliation
University of Pittsburgh, School of Medicine, Dept. Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Academic Pediatrics
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsburgh Department of Family Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://github.com/pittvax
Citations:
PubMed Identifier
32580919
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.
Results Reference
derived

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Immunologic Response to Influenza Vaccination in Children and Adolescents

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