Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
Public ClinicalTrials.gov record NCT00976027. 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
Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly. Primary objective: To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations. Secondary objectives: * To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus. * To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations.
Study identification
- NCT ID
- NCT00976027
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 9,172 participants
Conditions and interventions
Conditions
Interventions
- Trivalent inactivated influenza vaccine High Dose Biological
- Trivalent inactivated influenza vaccine Biological
Biological
Eligibility (public fields only)
- Age range
- 65 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
- Aug 31, 2009
- Primary completion
- Apr 30, 2011
- Completion
- Mar 31, 2012
- Last update posted
- Jul 31, 2012
2009 – 2012
United States locations
- U.S. sites
- 96
- U.S. states
- 33
- U.S. cities
- 89
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35209 | — |
| Not listed | Glendale | Arizona | 85308 | — |
| Not listed | Mesa | Arizona | 85203 | — |
| Not listed | Phoenix | Arizona | 85028 | — |
| Not listed | Phoenix | Arizona | 85050 | — |
| Not listed | Scottsdale | Arizona | 85251 | — |
| Not listed | Tempe | Arizona | 85283 | — |
| Not listed | Fountain Valley | California | 92708 | — |
| Not listed | Los Angeles | California | 90057 | — |
| Not listed | Oceanside | California | 92056 | — |
| Not listed | Sacramento | California | 95831 | — |
| Not listed | Santa Rosa | California | 95405 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Colorado Springs | Colorado | 80907 | — |
| Not listed | Colorado Springs | Colorado | 80909 | — |
| Not listed | Milford | Connecticut | 06460 | — |
| Not listed | Ridgefield | Connecticut | 06877 | — |
| Not listed | Celebration | Florida | 34747 | — |
| Not listed | Clearwater | Florida | 33756 | — |
| Not listed | Clearwater | Florida | 33761 | — |
| Not listed | Coral Gables | Florida | 33134 | — |
| Not listed | Crystal River | Florida | 34429 | — |
| Not listed | Cutler Bay | Florida | 33189 | — |
| Not listed | Deerfield Beach | Florida | 33442 | — |
| Not listed | Inverness | Florida | 34452 | — |
| Not listed | Jacksonville | Florida | 32205 | — |
| Not listed | Jacksonville | Florida | 32216 | — |
| Not listed | Melbourne | Florida | 32935 | — |
| Not listed | Miami | Florida | 33126 | — |
| Not listed | Pembroke Pines | Florida | 33026 | — |
| Not listed | Pinellas Park | Florida | 33781 | — |
| Not listed | Sarasota | Florida | 34239 | — |
| Not listed | South Miami | Florida | 33143 | — |
| Not listed | Stockbridge | Georgia | 30281 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Peoria | Illinois | 61602 | — |
| Not listed | South Bend | Indiana | 46601 | — |
| Not listed | Dubuque | Iowa | 52002 | — |
| Not listed | Arkansas City | Kansas | 67005 | — |
| Not listed | Lenexa | Kansas | 66219 | — |
| Not listed | Lexena | Kansas | 66215 | — |
| Not listed | Newton | Kansas | 67114 | — |
| Not listed | Overland Park | Kansas | 66212 | — |
| Not listed | Prairie Village | Kansas | 66206 | — |
| Not listed | Wichita | Kansas | 67205 | — |
| Not listed | Metairie | Louisiana | 70006 | — |
| Not listed | Columbia | Maryland | 21042 | — |
| Not listed | Elkridge | Maryland | 21075 | — |
| Not listed | Greenbelt | Maryland | 20770 | — |
| Not listed | Brockton | Massachusetts | 02301 | — |
| Not listed | Haverhill | Massachusetts | 01830 | — |
| Not listed | Chaska | Minnesota | 55318 | — |
| Not listed | Edina | Minnesota | 55435 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Missoula | Montana | 59808 | — |
| Not listed | Omaha | Nebraska | 68134 | — |
| Not listed | Las Vegas | Nevada | 89104 | — |
| Not listed | Rochester | New York | 14642 | — |
| Not listed | Cary | North Carolina | 27518 | — |
| Not listed | Charlotte | North Carolina | 28209 | — |
| Not listed | Hickory | North Carolina | 28601 | — |
| Not listed | High Point | North Carolina | 27262 | — |
| Not listed | Raleigh | North Carolina | 27607 | — |
| Not listed | Raleigh | North Carolina | 27612 | — |
| Not listed | Salisbury | North Carolina | 28144 | — |
| Not listed | Winston-Salem | North Carolina | 27103 | — |
| Not listed | Fargo | North Dakota | 58104 | — |
| Not listed | Akron | Ohio | 44311 | — |
| Not listed | Cleveland | Ohio | 44122 | — |
| Not listed | Columbus | Ohio | 43201 | — |
| Not listed | Columbus | Ohio | 43210 | — |
| Not listed | Columbus | Ohio | 43213 | — |
| Not listed | Norman | Oklahoma | 73069 | — |
| Not listed | Corvallis | Oregon | 97330 | — |
| Not listed | Portland | Oregon | 97203 | — |
| Not listed | Downingtown | Pennsylvania | 19335 | — |
| Not listed | Erie | Pennsylvania | 16506 | — |
| Not listed | Jefferson Hills | Pennsylvania | 15025 | — |
| Not listed | Penndel | Pennsylvania | 19047 | — |
| Not listed | Pittsburgh | Pennsylvania | 15241 | — |
| Not listed | Upper Saint Clair | Pennsylvania | 15241 | — |
| Not listed | Anderson | South Carolina | 29621 | — |
| Not listed | Clinton | South Carolina | 29325 | — |
| Not listed | Goose Creek | South Carolina | 29445 | — |
| Not listed | Greer | South Carolina | 29651 | — |
| Not listed | Bristol | Tennessee | 37620 | — |
| Not listed | Nashville | Tennessee | 37212 | — |
| Not listed | Fort Worth | Texas | 76107 | — |
| Not listed | Galveston | Texas | 77555 | — |
| Not listed | Houston | Texas | 77074 | — |
| Not listed | San Antonio | Texas | 78229 | — |
| Not listed | Salt Lake City | Utah | 84124 | — |
| Not listed | Fredericksburg | Virginia | 22401 | — |
| Not listed | Williamsburg | Virginia | 23185 | — |
| Not listed | Lakewood | Washington | 98499 | — |
| Not listed | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00976027, 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 Jul 31, 2012 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00976027 live on ClinicalTrials.gov.