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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: Completed Phase 2 study, sponsored by Stony Brook University.
NCT03277703 is a Phase 2 study that has completed, run by Stony Brook University. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
immunological vaccine response
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 |
What the finished NCT03277703 record still lists
NCT03277703 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Influenza vaccine is the first listed.
NCT03277703 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03277703's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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