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NCT03277703
Flu Vaccine Response in Patients on Biologic Therapies
Phase 2 trial testing Influenza vaccine in Rheumatologic Disorder in 30 participants. Completed in 1 January 2020.
1 January 2020
Quick facts
| Lead sponsor | Stony Brook University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 3 November 2017 |
| Primary completion | 1 January 2020 |
| Estimated completion | 1 January 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Influenza vaccine — full drug profile →
Conditions studied
- Rheumatologic Disorder — all drugs for Rheumatologic Disorder →
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
- Immune Complex Diseases — all drugs for Immune Complex Diseases →
Sponsor
Stony Brook University
Who can join
Adults 3 to 22, any sex, with Rheumatologic Disorder or Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03277703
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06279871 — Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults · Phase 3 · completed
- NCT05584735 — Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine · completed
Other Stony Brook University trials
Trials by the same sponsor.
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- NCT07114900 — Randomized Controlled Physical Activity App Intervention for Black Women · Phase 3 · active not recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03277703 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stony Brook University
- Last refreshed: 25 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03277703.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing