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Terminated Phase 3 Interventional Accepts healthy volunteers Results available

Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older

ClinicalTrials.gov ID: NCT00976027

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.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 11:29 PM EDT

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
Lead sponsor
Sanofi
Industry
Enrollment
9,172 participants

Conditions and interventions

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 2009 (Type not available)
Primary completion
May 2011 (Actual)
Completion
Apr 2012 (Actual)
Last update posted
Aug 1, 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 Aug 1, 2012 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00976027 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →