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Immunologic Response to Influenza Vaccination in Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03614975
Recruitment Status : Completed
First Posted : August 3, 2018
Results First Posted : November 12, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Richard Zimmerman MD, University of Pittsburgh

Study Description
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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).

Condition or disease Intervention/treatment Phase
Influenza, Human Immune Response Biological: Flucelvax inactivated influenza vaccine Biological: Fluzone inactivated influenza vaccine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunologic Response to Influenza Vaccination in Children and Adolescents: A RCT Trial of Influenza Vaccines
Actual Study Start Date : September 13, 2018
Actual Primary Completion Date : December 13, 2018
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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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.)


Outcome Measures
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Primary Outcome Measures :
  1. Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination [ Time Frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) ]
    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 :
  1. Determining Seroprotection Level at Each Time Point [ Time Frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) ]
    Hemagglutination inhibition assay will be conducted to assess immunologic outcome. Seroprotection is defined as a HI titer >= 1:110 at either time point.

  2. Determining Geometric Mean Titers (GMTs) at Each Time Point [ Time Frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) ]
    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


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614975


Locations
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United States, Pennsylvania
General Academic Pediatrics
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Department of Family Medicine
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
Richard Zimmerman MD
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Richard K Zimmerman, MD, MPH, MA University of Pittsburgh, School of Medicine, Dept. Family Medicine
  Study Documents (Full-Text)

Documents provided by Richard Zimmerman MD, University of Pittsburgh:
Study Protocol and Statistical Analysis Plan  [PDF] September 20, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Richard Zimmerman MD, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03614975    
Other Study ID Numbers: PRO18050091
CDCU01IP001035 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
First Posted: August 3, 2018    Key Record Dates
Results First Posted: November 12, 2019
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in the primary article, after deidentification, will be placed at the site mentioned below.
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months after article publication.
Access Criteria: Researchers who provide a methodologically sound proposal and have appropriate data security and privacy plans in place
URL: https://github.com/pittvax

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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
Keywords provided by Richard Zimmerman MD, University of Pittsburgh:
inactivated
influenza
vaccine
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs