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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: Completed Phase 3 study of Influenza, sponsored by Protein Sciences Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.
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 |
What the finished NCT01825200 record still lists
NCT01825200 is an interventional study that assigns participants to a tested intervention. Its 2,640 participants enrollment target places it among the larger protocols in the corpus, below the 36,787-participant average among 156 other Influenza trials with a reported enrollment target (93% lower).
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 lists 14 locations in 12 states (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.
Where NCT01825200's enrollment target sits among peer trials
2,640 25th of 156 higher than 132 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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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