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InfluenzaPhase 3NCT00976027

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

A Phase 3 study testing Trivalent inactivated influenza vaccine High Dose and Trivalent inactivated influenza vaccine in people with Influenza, run by Sanofi at 98 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Trivalent inactivated influenza vaccine High Dose and Trivalent inactivated influenza vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,172 participants
Where
98 sitesin 2 countries
Study dates
Sep 2009to Apr 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Aged ≥ 65 years on the day of vaccination
  • Informed consent form signed and dated.
  • Able to attend all scheduled visits and to comply with all trial procedures.

Who cannot join

  • Participation in another interventional clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure in the 4 weeks preceding the trial vaccination or planned participation in another clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure during each year of participation in the study trial.
  • Vaccination against influenza in the 6 months preceding the trial vaccination.
  • Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone vaccine or to a vaccine containing any of the same substances.
  • Personal history of Guillain-Barré syndrome.
  • Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures.
  • Thrombocytopenia, bleeding disorder, or anticoagulation therapy contraindicating intramuscular (IM) vaccination.
Show all 10Show fewer
  • Known or suspected human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C seropositivity.
  • Alcohol abuse or drug addiction that could interfere with the subject's ability to comply with trial procedures.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Bedridden subjects.

Trial locations and contacts

98 sites in 2 countries.

98 sites in 2 countries

United States96 sites

  • Study site

    Akron, Ohio, 44311

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Arkansas City, Kansas, 67005

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Cary, North Carolina, 27518

  • Study site

    Celebration, Florida, 34747

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Chaska, Minnesota, 55318

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Clearwater, Florida, 33761

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Clinton, South Carolina, 29325

  • Study site

    Colorado Springs, Colorado, 80907

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Columbia, Maryland, 21042

  • Study site

    Columbus, Ohio, 43201

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Corvallis, Oregon, 97330

  • Study site

    Crystal River, Florida, 34429

  • Study site

    Cutler Bay, Florida, 33189

  • Study site

    Deerfield Beach, Florida, 33442

  • Study site

    Downingtown, Pennsylvania, 19335

  • Study site

    Dubuque, Iowa, 52002

  • Study site

    Edina, Minnesota, 55435

  • Study site

    Elkridge, Maryland, 21075

  • Study site

    Erie, Pennsylvania, 16506

  • Study site

    Fargo, North Dakota, 58104

  • Study site

    Fort Worth, Texas, 76107

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Fredericksburg, Virginia, 22401

  • Study site

    Galveston, Texas, 77555

  • Study site

    Glendale, Arizona, 85308

  • Study site

    Goose Creek, South Carolina, 29445

  • Study site

    Greenbelt, Maryland, 20770

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Haverhill, Massachusetts, 01830

  • Study site

    Hickory, North Carolina, 28601

  • Study site

    High Point, North Carolina, 27262

  • Study site

    Houston, Texas, 77074

  • Study site

    Inverness, Florida, 34452

  • Study site

    Jacksonville, Florida, 32205

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jefferson Hills, Pennsylvania, 15025

  • Study site

    Lakewood, Washington, 98499

  • Study site

    Las Vegas, Nevada, 89104

  • Study site

    Lenexa, Kansas, 66219

  • Study site

    Lexena, Kansas, 66215

  • Study site

    Los Angeles, California, 90057

  • Study site

    Marshfield, Wisconsin, 54449

  • Study site

    Melbourne, Florida, 32935

  • Study site

    Mesa, Arizona, 85203

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33126

  • Study site

    Milford, Connecticut, 06460

  • Study site

    Missoula, Montana, 59808

  • Study site

    Nashville, Tennessee, 37212

  • Study site

    Newton, Kansas, 67114

  • Study site

    Norman, Oklahoma, 73069

  • Study site

    Oceanside, California, 92056

  • Study site

    Omaha, Nebraska, 68134

  • Study site

    Overland Park, Kansas, 66212

  • Study site

    Pembroke Pines, Florida, 33026

  • Study site

    Penndel, Pennsylvania, 19047

  • Study site

    Peoria, Illinois, 61602

  • Study site

    Phoenix, Arizona, 85028

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Pittsburgh, Pennsylvania, 15241

  • Study site

    Portland, Oregon, 97203

  • Study site

    Prairie Village, Kansas, 66206

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Ridgefield, Connecticut, 06877

  • Study site

    Rochester, New York, 14642

  • Study site

    Sacramento, California, 95831

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    Salt Lake City, Utah, 84124

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Santa Rosa, California, 95405

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Scottsdale, Arizona, 85251

  • Study site

    South Bend, Indiana, 46601

  • Study site

    South Miami, Florida, 33143

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Stockbridge, Georgia, 30281

  • Study site

    Tempe, Arizona, 85283

  • Study site

    Upper Saint Clair, Pennsylvania, 15241

  • Study site

    Wichita, Kansas, 67205

  • Study site

    Williamsburg, Virginia, 23185

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico2 sites

  • Study site

    San Juan, 00918

  • Study site

    Toa Baja, 00949

Other trials in Puerto Rico

About this study

Official title: Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age

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:

Read more

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.
Read the detailed description

The occurrence of influenza-like illness (ILI) will be determined in elderly participants vaccinated with either Fluzone High Dose or Fluzone® vaccine.

The presence of influenza virus in the respiratory tract of vaccinated individuals with ILI will be confirmed by two methods.

Conditions
Influenza
Being tested
Trivalent inactivated influenza vaccine High Dose, Trivalent inactivated influenza vaccine
Keywords
Influenza, Respiratory Tract Infections, Influenza-like illness, Elderly, Fluzone®, Efficacy
Medical subject headings
Influenza, Human, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trivalent inactivated influenza vaccine High DoseBiological

    Also called Fluzone® High Dose

    0.5 mL, Intramuscular

  • Trivalent inactivated influenza vaccineBiological

    Also called Fluzone®

    0.5 mL, Intramuscular

Study groups in NCT00976027
Study groupRoleWhat they receive
Fluzone® High Dose GroupExperimentalNot described
Receives: Biological: Trivalent inactivated influenza vaccine High Dose
Fluzone® GroupActive comparatorNot described
Receives: Biological: Trivalent inactivated influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.

    The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.

    Measured: Day 0 (pre-vaccination) up to Year 1 post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMay 2011
  4. Study completionApr 2012

Why it stopped: No safety concerns, study terminated due to lack of primary endpoint cases in 2009-2010 Flu season (coincided with H1N1 Pandemic) Subjects followed per-protocol

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
9,172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00976027
Sponsor's protocol ID
FIM07
Other IDs
UTN: U1111-1111-4478
Status last verified
Jul 2012
First submitted
11 Sep 2009
Last updated
1 Aug 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trivalent inactivated influenza vaccine High Dose and Trivalent inactivated influenza vaccine in people with Influenza, run by Sanofi at 98 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations. (time frame: Day 0 (pre-vaccination) up to Year 1 post-vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00976027.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.

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