A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
Public ClinicalTrials.gov record NCT01427309. 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.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
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 compared to standard dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for culture-confirmed) to those contained in the respective annual vaccine formulations. Primary Objective: * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined influenza-like-illnesses (ILI). Secondary Objectives: * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations, associated with the occurrence of a modified Centers for Disease Control and Prevention (CDC)-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a modified CDC-defined ILI. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations, associated with the occurrence of a respiratory illness. * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a respiratory illness.
Study identification
- NCT ID
- NCT01427309
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 31,989 participants
Conditions and interventions
Conditions
Interventions
- High Dose Trivalent Inactivated Influenza Vaccine 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
- Sep 2011 (Type not available)
- Primary completion
- May 2013 (Actual)
- Completion
- Nov 2013 (Actual)
- Last update posted
- Apr 20, 2015
2011 – 2013
United States locations
- U.S. sites
- 105
- U.S. states
- 35
- U.S. cities
- 91
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Mobile | Alabama | 36608 | — |
| Not listed | Chandler | Arizona | 85224 | — |
| Not listed | Glendale | Arizona | 85306 | — |
| Not listed | Glendale | Arizona | 85308 | — |
| Not listed | Mesa | Arizona | 85203 | — |
| Not listed | Mesa | Arizona | 85213 | — |
| Not listed | Phoenix | Arizona | 85020 | — |
| Not listed | Phoenix | Arizona | 85028 | — |
| Not listed | Phoenix | Arizona | 85050 | — |
| Not listed | Scottsdale | Arizona | 85251 | — |
| Not listed | Tempe | Arizona | 85283 | — |
| Not listed | Harrisburg | Arkansas | 72432 | — |
| Not listed | Anaheim | California | 92801 | — |
| Not listed | La Mesa | California | 91942 | — |
| Not listed | Oceanside | California | 92056 | — |
| Not listed | Redding | California | 96001 | — |
| Not listed | San Diego | California | 92103 | — |
| Not listed | Santa Rosa | California | 95405 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Colorado Springs | Colorado | 80907 | — |
| Not listed | Colorado Springs | Colorado | 80922 | — |
| Not listed | Milford | Connecticut | 01757 | — |
| Not listed | Milford | Connecticut | 06460 | — |
| Not listed | Brooksville | Florida | 34601 | — |
| Not listed | Clearwater | Florida | 33756 | — |
| Not listed | Clearwater | Florida | 33761 | — |
| Not listed | Coral Gables | Florida | 33134 | — |
| Not listed | Crystal River | Florida | 34429 | — |
| Not listed | DeLand | Florida | 32720 | — |
| Not listed | Jacksonville | Florida | 32216 | — |
| Not listed | Melbourne | Florida | 32935 | — |
| Not listed | Pembroke Pine | Florida | 33026 | — |
| Not listed | Pinellas Park | Florida | 33781 | — |
| Not listed | Sarasota | Florida | 34231 | — |
| Not listed | Stockbridge | Georgia | 30281 | — |
| Not listed | Boise | Idaho | 83642 | — |
| Not listed | Chicago | Illinois | 60654 | — |
| Not listed | Peoria | Illinois | 61602 | — |
| Not listed | Mishawaka | Indiana | 46545 | — |
| Not listed | Lenexa | Kansas | 66219 | — |
| Not listed | Newton | Kansas | 67114 | — |
| Not listed | Overland Park | Kansas | 66212 | — |
| Not listed | Prairie Village | Kansas | 66206 | — |
| Not listed | Wichita | Kansas | 67205 | — |
| Not listed | Wichita | Kansas | 67207 | — |
| Not listed | Bardstown | Kentucky | 40004 | — |
| Not listed | Lexington | Kentucky | 40504 | — |
| Not listed | Columbia | Maryland | 21045 | — |
| Not listed | Elkridge | Maryland | 21075 | — |
| Not listed | Rockville | Maryland | 20850 | — |
| Not listed | Brockton | Massachusetts | 02301 | — |
| Not listed | Haverhill | Massachusetts | 01830 | — |
| Not listed | Edina | Minnesota | 55435 | — |
| Not listed | Kansas City | Missouri | 64114 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Missoula | Montana | 59808 | — |
| Not listed | Bellevue | Nebraska | 68005 | — |
| Not listed | Omaha | Nebraska | 68114 | — |
| Not listed | Las Vega | Nevada | 89104 | — |
| Not listed | Newington | New Hampshire | 03801 | — |
| Not listed | Edison | New Jersey | 08817 | — |
| Not listed | Albuquerque | New Mexico | 87018 | — |
| Not listed | Binghamton | New York | 13901 | — |
| Not listed | Endwell | New York | 13760 | — |
| Not listed | Rochester | New York | 14609 | — |
| Not listed | Rochester | New York | 14642 | — |
| Not listed | Cary | North Carolina | 27518 | — |
| Not listed | Charlotte | North Carolina | 28209 | — |
| Not listed | Hickory | North Carolina | 28602 | — |
| Not listed | Raleigh | North Carolina | 27609 | — |
| Not listed | Raleigh | North Carolina | 27612 | — |
| Not listed | Salisbury | North Carolina | 28144 | — |
| Not listed | Wilmington | North Carolina | 28401 | — |
| Not listed | Winston-Salem | North Carolina | 27103 | — |
| Not listed | Fargo | North Dakota | 58104 | — |
| Not listed | Idaho Falls | North Dakota | 83404 | — |
| Not listed | Akron | Ohio | 44311 | — |
| Not listed | Cincinnati | Ohio | 45227 | — |
| Not listed | Cincinnati | Ohio | 45259 | — |
| Not listed | Cleveland | Ohio | 44122 | — |
| Not listed | Columbus | Ohio | 43213 | — |
| Not listed | Norman | Oklahoma | 73069 | — |
| Not listed | Erie | Pennsylvania | 16506 | — |
| Not listed | Pittsburgh | Pennsylvania | 15241 | — |
| Not listed | Scranton | Pennsylvania | 18510 | — |
| Not listed | Warwick | Rhode Island | 02886 | — |
| Not listed | Anderson | South Carolina | 29621 | — |
| Not listed | Clinton | South Carolina | 29325 | — |
| Not listed | Greer | South Carolina | 29650 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Spartanburg | South Carolina | 29303 | — |
| Not listed | Bristol | Tennessee | 37620 | — |
| Not listed | Nashville | Tennessee | 37203 | — |
| Not listed | Nashville | Tennessee | 37212 | — |
| Not listed | Fort Worth | Texas | 76107 | — |
| Not listed | San Antonio | Texas | 78229 | — |
| Not listed | Tomball | Texas | 77375 | — |
| Not listed | Salt Lake City | Utah | 84109 | — |
| Not listed | Salt Lake City | Utah | 84121 | — |
| Not listed | Salt Lake City | Utah | 84124 | — |
| Not listed | South Jordan | Utah | 84095 | — |
| Not listed | West Jordan | Utah | 84088 | — |
| Not listed | Norfolk | Virginia | 23507 | — |
| Not listed | Williamsburg | Virginia | 23185 | — |
| Not listed | Winchester | Virginia | 22601 | — |
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 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01427309, 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 Apr 20, 2015 · Synced Nov 7, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01427309 live on ClinicalTrials.gov.