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Immunologic Response to FluMist vs. Flucelvax

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ClinicalTrials.gov Identifier: NCT03982069
Recruitment Status : Completed
First Posted : June 11, 2019
Last Update Posted : December 17, 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 4-21 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).

Condition or disease Intervention/treatment Phase
Influenza, Human Immune Response Biological: FluMist live attenuated influenza vaccine Biological: Flucelvax 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 4-21 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 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 : 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax
Actual Study Start Date : September 20, 2019
Actual Primary Completion Date : December 9, 2020
Actual Study Completion Date : December 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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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.


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 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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): NCT03982069


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
More Information
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Responsible Party: Richard Zimmerman MD, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03982069    
Other Study ID Numbers: STUDY19040242
1U01|P001035-01 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 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: http://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
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
 Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs