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NCT03277703 · ClinicalTrials.gov registry record · Phase 2
Flu Vaccine Response in Patients on Biologic Therapies
A Phase 2 study, sponsored by Stony Brook University.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT03277703 is a Phase 2 study that has completed, run by Stony Brook University. The registered enrollment target is 30 participants.
The verdict
NCT03277703, a Phase 2 study, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive therapies. Investigators will compare serologic responses to single versus a booster dose of influenza vaccine in patients with inflammatory bowel disease (IBD- Crohn's Disease or Ulcerative Colitis) or rheumatologic diseases who are receiving immunosuppressive therapies. Subjects will be randomized to receive either one or two doses of influenza vaccination in year #1. In year# 2, all participants will be given two doses of influenza vaccine. Serologic responses will be measured pre and 4-6 weeks post vaccination. This study will also assess the immunogenicity and safety of a booster vaccine strategy in the prevention of influenza-like illness (ILI). Investigators anticipate that booster dose strategy will improve both clinical and serologic responses in this vulnerable population.
Interventions
- BIOLOGICAL Influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-11-03 |
| Est. Completion | 2020-01-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03277703
The ClinicalTrials.gov registry entry for NCT03277703 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stony Brook University, which has 127 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Influenza vaccine is the first listed.
NCT03277703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03277703 about?
NCT03277703 is a clinical study titled "Flu Vaccine Response in Patients on Biologic Therapies". This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive therapies. Investigators will compare serologic responses to single versus a booster dose of influe...
What is the current status of trial NCT03277703?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2017-11-03. Estimated completion is 2020-01-01.
What interventions are being tested in trial NCT03277703?
The interventions under investigation include: Influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03277703?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
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