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Influenza Vaccine Booster in Children With Rheumatic Diseases and IBD on Immunosuppressive Therapies
NCT03277703Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2017
- Primary completion
- Dec 2019
- Countries
- 1
- Sponsor
- Stony Brook University
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- influenza vaccine
- Conditions
- influenza
01
Overview
Phase 2, randomised trial of influenza vaccine in influenza (4 arms), sponsored by Stony Brook University. Primary endpoint: Influenza Hemagglutination Inhibition Titer. Started Nov 2017; status: completed.
02
Design
4 arms- Study design
- Randomized
Group 1 - Booster - Year 1
Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1
Group 2 - Standard - Year 1
Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1
Group 1 - Booster - Year 2
Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2
Group 2 - Standard - Year 2
Group 2 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2
03
Who it enrols
Children ages 3-22 with rheumatologic conditions or IBD receiving specific immunosuppressive therapies, excluding those with severe egg allergy, prior Guillain-Barre syndrome, or recent use of certain excluded medications.
04
Endpoints
Primary
Influenza Hemagglutination Inhibition Titer
Secondary
Number of Participants With Decreased Influenza Rates Per Strain
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