Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
Public ClinicalTrials.gov record NCT01825200. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Comparison of the Safety of Flublok® Versus Licensed Inactivated Influenza Vaccine in Healthy, Medically Stable Adults ≥ 50 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01825200
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,640 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2013
- Primary completion
- Apr 30, 2013
- Completion
- Apr 30, 2013
- Last update posted
- Feb 17, 2015
2013
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Genova Clinical Research | Tucson | Arizona | 85704-1152 | — |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | — |
| Meridian Clinical Research | Savannah | Georgia | 31406 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| Benchmark Research | Metairie | Louisiana | 70006 | — |
| Maine Research Associates, LLC | Auburn | Maine | 04210 | — |
| Meridian Clinical Research | Omaha | Nebraska | 68164 | — |
| Clinical Research Center of Nevada, LLC | Las Vegas | Nevada | 89104 | — |
| Regional Clinical Research | Binghamton | New York | 13901 | — |
| Wake Research | Raleigh | North Carolina | 27612 | — |
| Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | — |
| Research Across America | Dallas | Texas | 75234 | — |
| Benchmark Research | Fort Worth | Texas | 76135 | — |
| Benchmark Research | San Angelo | Texas | 76904 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01825200, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 17, 2015 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01825200 live on ClinicalTrials.gov.