Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01825200 · ClinicalTrials.gov registry record · Phase 3
Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
A Phase 3 study of Influenza, sponsored by Protein Sciences Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,640
- Enrollment target
- 14
- Study locations
NCT01825200 is a Phase 3 study of Influenza that has completed, run by Protein Sciences Corporation. The registered enrollment target is 2,640 participants, below the 36,787-participant average among 156 other Influenza trials with a reported enrollment target (93% lower). The trial reports 14 study locations across 12 states.
The verdict
NCT01825200, a Phase 3 study of Influenza, has completed, sponsored by Protein Sciences Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,640 participants
- Enrollment target
- 14
- Study locations
Study Summary
The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety profiles previously observed with Flublok and with the licensed comparator.
Conditions Studied
Interventions
- BIOLOGICAL Afluria
- BIOLOGICAL Flublok
Study Locations (14)
Texas
- Research Across America - Dallas
- Benchmark Research - Fort Worth
- Benchmark Research - San Angelo
Arizona
- Genova Clinical Research - Tucson
Florida
- Clinical Research of South Florida - Coral Gables
Georgia
- Meridian Clinical Research - Savannah
Kansas
- Heartland Research Associates, LLC - Wichita
Louisiana
- Benchmark Research - Metairie
Maine
- Maine Research Associates, LLC - Auburn
Nebraska
- Meridian Clinical Research - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,640 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01825200
The ClinicalTrials.gov registry entry for NCT01825200 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,640 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,787-participant average among 156 other Influenza trials with a reported enrollment target (93% lower). The listed sponsor is Protein Sciences Corporation, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Afluria is the first listed.
NCT01825200 reports 14 study locations spanning 12 distinct geographic areas - top geographies include Texas, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT01825200 about?
NCT01825200 is a clinical study titled "Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age". The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acc...
What is the current status of trial NCT01825200?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,640 participants. The study started on 2013-03. Estimated completion is 2013-05.
What conditions does trial NCT01825200 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01825200?
The interventions under investigation include: Afluria (BIOLOGICAL), Flublok (BIOLOGICAL).
Who is sponsoring clinical trial NCT01825200?
This trial is sponsored by Protein Sciences Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01825200 being conducted?
This trial has 14 study locations across Arizona, Florida, Georgia, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
RECRUITING · Phase 3
-
A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza
ACTIVE NOT RECRUITING · Phase 3
-
Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
COMPLETED · Phase 3
-
Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age
COMPLETED · Phase 3
-
Study of Quadrivalent Influenza Vaccine Among Children
COMPLETED · Phase 3
-
Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.