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NCT01436370 · ClinicalTrials.gov registry record · Phase 2
TIV and High Dose TIV in Subjects With Rheumatoid Arthritis
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT01436370 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 102 participants.
The verdict
NCT01436370, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
A randomized, double-blinded, Phase II study in adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy aged 18 to 64 years of age and healthy gender-and age-matched control subjects . This study will investigate the immunogenicity, safety, and reactogenicity of two different doses of inactivated trivalent influenza virus vaccine (Sanofi Pasteur Fluzone \[15 mcg x 3 strains\] and Sanofi Pasteur Fluzone High Dose \[60 mcg x 3 strains\]) administered intramuscularly in individuals with rheumatoid arthritis receiving anti-TNF-alpha (TNFi) therapy and healthy age- and gender- matched controls.
Interventions
- BIOLOGICAL Trivalent inactivated influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01436370
The ClinicalTrials.gov registry entry for NCT01436370 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Trivalent inactivated influenza vaccine is the first listed.
NCT01436370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01436370 about?
NCT01436370 is a clinical study titled "TIV and High Dose TIV in Subjects With Rheumatoid Arthritis". A randomized, double-blinded, Phase II study in adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy aged 18 to 64 years of age and healthy gender-and age-matched control subjects . This study will investigate the immunogenicity, safety, and reactogenicity of two different doses of...
What is the current status of trial NCT01436370?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2011-10. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01436370?
The interventions under investigation include: Trivalent inactivated influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01436370?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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