Immunologic Response to FluMist vs. Flucelvax
Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax
2 other identifiers
interventional
465
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2019
CompletedFirst Posted
Study publicly available on registry
June 11, 2019
CompletedStudy Start
First participant enrolled
September 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2020
CompletedResults Posted
Study results publicly available
October 14, 2021
CompletedOctober 14, 2021
September 1, 2021
1.2 years
June 6, 2019
August 18, 2021
September 17, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Number of Participants With Seroprotection Response in 2019
Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Geometric Mean Titers (GMTs) at Each Time Point 2019
Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Number of Participants With Seroprotection Response in 2020
Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Geometric Mean Titers (GMTs) at Each Time Point 2020
Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Study Arms (2)
FluMist live attenuated influenza vaccine
ACTIVE COMPARATORParticipants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
Flucelvax inactivated influenza vaccine
ACTIVE COMPARATORParticipants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Interventions
Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Richard Zimmerman MDlead
- Centers for Disease Control and Preventioncollaborator
Study Sites (2)
General Academic Pediatrics
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburgh Department of Family Medicine
Pittsburgh, Pennsylvania, 15260, United States
Related Publications (1)
Williams KV, Li ZN, Zhai B, Alcorn JF, Nowalk MP, Levine MZ, Kim SS, Flannery B, Moehling Geffel K, Merranko AJ, Collins M, Susick M, Clarke KS, Zimmerman RK, Martin JM. A Randomized Controlled Trial to Compare Immunogenicity to Cell-Based Versus Live-Attenuated Influenza Vaccines in Children. J Pediatric Infect Dis Soc. 2023 Jun 30;12(6):342-352. doi: 10.1093/jpids/piad033.
PMID: 37232430DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Katherine Williams
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Richard K Zimmerman, MD, MPH, MA
University of Pittsburgh, School of Medicine, Dept. Family Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 6, 2019
First Posted
June 11, 2019
Study Start
September 20, 2019
Primary Completion
December 9, 2020
Study Completion
December 9, 2020
Last Updated
October 14, 2021
Results First Posted
October 14, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- 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
Individual participant data that underlie the results reported in the primary article, after deidentification, will be placed at the site mentioned below.