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InfluenzaPhase 4NCT01427309

A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

A Phase 4 study testing High Dose Trivalent Inactivated Influenza Vaccine and Trivalent Inactivated Influenza Vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 113 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… 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?
High Dose Trivalent Inactivated Influenza Vaccine and Trivalent Inactivated Influenza Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31,989 participants
Where
113 sitesin 3 countries
Study dates
Sep 2011to Nov 2013
Phase
Phase 4
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 at the time of study enrollment (or in the 4 weeks preceding the trial vaccination), or planned participation during each year of the trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure (Note: Concomitant participation in an observational trial is acceptable)
  • 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 High-Dose or 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 contraindicating intramuscular (IM) vaccination, as judged by the investigator
Show all 12Show fewer
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination, as judged by the investigator
  • Current alcohol abuse or drug addiction
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
  • Moderate or severe acute illness with or without fever (oral temperature > 99.0ºF [> 37.2ºC]). If this contraindication exists, vaccination will be deferred until the individual has been medically stable and/or afebrile (temperature ≤ 99.0 ºF [≤ 37.2ºC]) for at least 24 hours
  • Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.

Trial locations and contacts

113 sites in 3 countries.

113 sites in 3 countries

United States105 sites

  • Study site

    Akron, Ohio, 44311

  • Study site

    Albuquerque, New Mexico, 87018

  • Study site

    Anaheim, California, 92801

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Bardstown, Kentucky, 40004

  • Study site

    Bellevue, Nebraska, 68005

  • Study site

    Binghamton, New York, 13901

  • Study site

    Boise, Idaho, 83642

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Brooksville, Florida, 34601

  • Study site

    Cary, North Carolina, 27518

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Chicago, Illinois, 60654

  • Study site

    Cincinnati, Ohio, 45227

  • Study site

    Cincinnati, Ohio, 45259

  • 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, 80922

  • Study site

    Columbia, Maryland, 21045

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Crystal River, Florida, 34429

  • Study site

    DeLand, Florida, 32720

  • Study site

    Edina, Minnesota, 55435

  • Study site

    Edison, New Jersey, 08817

  • Study site

    Elkridge, Maryland, 21075

  • Study site

    Endwell, New York, 13760

  • Study site

    Erie, Pennsylvania, 16506

  • Study site

    Fargo, North Dakota, 58104

  • Study site

    Fort Worth, Texas, 76107

  • Study site

    Glendale, Arizona, 85306

  • Study site

    Glendale, Arizona, 85308

  • Study site

    Greer, South Carolina, 29650

  • Study site

    Harrisburg, Arkansas, 72432

  • Study site

    Haverhill, Massachusetts, 01830

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Idaho Falls, North Dakota, 83404

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    La Mesa, California, 91942

  • Study site

    Las Vega, Nevada, 89104

  • Study site

    Lenexa, Kansas, 66219

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Melbourne, Florida, 32935

  • Study site

    Mesa, Arizona, 85203

  • Study site

    Mesa, Arizona, 85213

  • Study site

    Milford, Connecticut, 01757

  • Study site

    Milford, Connecticut, 06460

  • Study site

    Mishawaka, Indiana, 46545

  • Study site

    Missoula, Montana, 59808

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Nashville, Tennessee, 37212

  • Study site

    Newington, New Hampshire, 03801

  • Study site

    Newton, Kansas, 67114

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Norman, Oklahoma, 73069

  • Study site

    Oceanside, California, 92056

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Overland Park, Kansas, 66212

  • Study site

    Pembroke Pine, Florida, 33026

  • Study site

    Peoria, Illinois, 61602

  • Study site

    Phoenix, Arizona, 85020

  • Study site

    Phoenix, Arizona, 85028

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Pittsburgh, Pennsylvania, 15241

  • Study site

    Prairie Village, Kansas, 66206

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Redding, California, 96001

  • Study site

    Rochester, New York, 14609

  • Study site

    Rochester, New York, 14642

  • Study site

    Rockville, Maryland, 20850

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    Salt Lake City, Utah, 84124

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92103

  • Study site

    Santa Rosa, California, 95405

  • Study site

    Sarasota, Florida, 34231

  • Study site

    Scottsdale, Arizona, 85251

  • Study site

    Scranton, Pennsylvania, 18510

  • Study site

    South Jordan, Utah, 84095

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Stockbridge, Georgia, 30281

  • Study site

    Tempe, Arizona, 85283

  • Study site

    Tomball, Texas, 77375

  • Study site

    Warwick, Rhode Island, 02886

  • Study site

    West Jordan, Utah, 84088

  • Study site

    Wichita, Kansas, 67205

  • Study site

    Wichita, Kansas, 67207

  • Study site

    Williamsburg, Virginia, 23185

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winchester, Virginia, 22601

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada6 sites

  • Study site

    Coquitlam, British Columbia, V3K3P4

  • Study site

    Greater Sudbury, Ontario, P3E1H5

  • Study site

    Mount Pearl, Newfoundland and Labrador, A1N1W7

  • Study site

    Sherbrooke, Quebec, J1H4J6

  • Study site

    Toronto, Ontario, M9W4L6

  • Study site

    Truro, Nova Scotia, B2N1L2

Other trials in Canada

Puerto Rico2 sites

  • Study site

    Bayamón, 00961

  • Study site

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: Efficacy Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

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:

Read more
  • 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.
Read the detailed description

The trial will span 2 influenza seasons. Each study year, participants will be randomized to receive one dose of either Fluzone® High-Dose or Fluzone® vaccine prior to the start of the influenza season and will be followed until the end of each season.

The duration of each participant's participation in the respective study year will be 6 to 8 months, depending on the time of enrollment.

Conditions
Influenza
Being tested
High Dose Trivalent Inactivated Influenza Vaccine, Trivalent Inactivated Influenza Vaccine
Keywords
Influenza, Trivalent Inactivated Influenza Vaccine, High-Dose Trivalent Inactivated Influenza Vaccine, Fluzone® High-Dose, Influenza vaccines
Medical subject headings
Influenza, Human

What participants receive

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

  • High Dose Trivalent Inactivated Influenza VaccineBiological

    Also called Fluzone® High Dose

    0.5 mL Intramuscular

  • Trivalent Inactivated Influenza VaccineBiological

    Also called Fluzone®

    0.5 mL, Intramuscular

Study groups in NCT01427309
Study groupRoleWhat they receive
High Dose Trivalent Inactivated Influenza VaccineExperimentalParticipants will receive an injection of High Dose Trivalent Inactivated Influenza Vaccine
Receives: Biological: High Dose Trivalent Inactivated Influenza Vaccine
Trivalent Inactivated Influenza VaccineActive comparatorParticipants will receive an injection of the Trivalent Inactivated Influenza vaccine
Receives: Biological: Trivalent Inactivated Influenza Vaccine

What is being measured

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

  1. Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness (ILI).

    Influenza positive cultures were confirmed using direct immunofluorescence techniques with influenza type-specific antibodies. 3 culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). The initial molecular test (PCR) was the validated ProFlu+™ assay by Prodesse, Inc., Waukesha, WI, which had been approved by the Food and Drug Administration through a 510K evaluation for specific detection of Influenza A, B or Respiratory Syncytial Virus.

    A protocol-defined influenza-like illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature > 99.0°F [> 37.2°C]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches).

    Measured: ≥14 days post-vaccination

Secondary outcomes (6)

  1. Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Protocol-defined Influenza-like Illness (ILI)

    Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture. For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.

    Measured: ≥14 days post-vaccination

  2. Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness

    For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture).

    A protocol-defined influenza-like illness (ILI) was determined by the occurrence of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature > 99.0°F [> 37.2°C]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches).

    Measured: ≥14 days post-vaccination

  3. Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Modified CDC-defined Influenza-like Illness.

    Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.

    The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat.

    Measured: ≥14 days post-vaccination

  4. Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Modified CDC-defined Influenza-like Illness

    Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.

    The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat.

    Measured: ≥14 days post-vaccination

  5. Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Respiratory Illness

    Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.

    Respiratory illness was defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing.

    Measured: ≥14 days post-vaccination

  6. Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Respiratory Illness

    Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture).

    Respiratory illness is defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing.

    Measured: ≥14 days 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 posted1 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMay 2013
  4. Study completionNov 2013

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
31,989 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01427309
Sponsor's protocol ID
FIM12
Other IDs
U1111-1120-1300
Status last verified
Mar 2015
First submitted
30 Aug 2011
Last updated
20 Apr 2015
Data monitoring committee
Yes

Publications

  • DiazGranados CA, Dunning AJ, Kimmel M, Kirby D, Treanor J, Collins A, Pollak R, Christoff J, Earl J, Landolfi V, Martin E, Gurunathan S, Nathan R, Greenberg DP, Tornieporth NG, Decker MD, Talbot HK. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014 Aug 14;371(7):635-45. doi: 10.1056/NEJMoa1315727.

    PubMed 25119609

  • Becker DL, Chit A, DiazGranados CA, Maschio M, Yau E, Drummond M. High-dose inactivated influenza vaccine is associated with cost savings and better outcomes compared to standard-dose inactivated influenza vaccine in Canadian seniors. Hum Vaccin Immunother. 2016 Dec;12(12):3036-3042. doi: 10.1080/21645515.2016.1215395. Epub 2016 Sep 26.

    PubMed 27669017

  • Dunning AJ, DiazGranados CA, Voloshen T, Hu B, Landolfi VA, Talbot HK. Correlates of Protection against Influenza in the Elderly: Results from an Influenza Vaccine Efficacy Trial. Clin Vaccine Immunol. 2016 Jan 13;23(3):228-35. doi: 10.1128/CVI.00604-15.

    PubMed 26762363

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing High Dose Trivalent Inactivated Influenza Vaccine and Trivalent Inactivated Influenza Vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 113 sites in 3 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 12 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: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, Canada, 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 6 Aug 2014). 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?

Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness (ILI). (time frame: ≥14 days 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 NCT01427309, which also lists 3 linked publications.

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 20 Apr 2015.

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