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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: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
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 |
What the finished NCT01436370 record still lists
NCT01436370 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which Trivalent inactivated influenza vaccine is the first listed.
NCT01436370 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01436370's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 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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