Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly

April 12, 2016 updated by: Sanofi Pasteur, a Sanofi Company

Phase III Lot Consistency, Immunogenicity and Safety Study of Three Lots of Fluzone High Dose Vaccine Compared With One Lot of Standard Fluzone® in Adults ≥ 65 Years of Age.

Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at higher risk for influenza-related morbidity and mortality, represents an important unmet need.

Primary Objectives:

Immunogenicity:

  • To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing process through evaluation of the immune responses elicited by three different lots.
  • To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone® vaccine.

Secondary Objectives:

Immunogenicity:

  • To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone® vaccine.

Safety:

  • To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited adverse and serious adverse events post-vaccination.
  • To describe clinical information on some additional defined criteria during the six months following vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3851

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States
      • Phoenix, Arizona, United States
      • Tempe, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • San Diego, California, United States
    • Connecticut
      • Stratford, Connecticut, United States
    • Florida
      • Clearwater, Florida, United States
      • Coral Gables, Florida, United States
      • Orlando, Florida, United States
      • Pembroke Pines, Florida, United States
    • Kansas
      • Wichita, Kansas, United States
    • Maryland
      • Rockville, Maryland, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
      • St. Louis, Missouri, United States
    • New York
      • Endwell, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Cary, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Pennsylvania
      • Downington, Pennsylvania, United States
      • Erie, Pennsylvania, United States
    • Rhode Island
      • Warwick, Rhode Island, United States
    • Texas
      • Dallas, Texas, United States
      • Plano, Texas, United States
    • Utah
      • West Jordan, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Wisconsin
      • Marshfield, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥ 65 years on the day of vaccination.
  • Informed consent form signed.
  • Medically stable. (Subjects may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled. If they are on medication for a condition, the medication dose must have been stable for at least 3 weeks preceding vaccination.)
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Fluzone® vaccine or a vaccine containing any of the same substances.
  • Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months.
  • Systemic corticosteroid therapy, as follows:

Continuous use with a dosage equivalent to > 15 mg/day of oral prednisone for 90 days preceding vaccination.

Sporadic use with a dosage equivalent to > 40 mg/day of oral prednisone for > 14 consecutive days in the 90 days preceding vaccination.

Note:Use of topical or inhalant corticosteroids is acceptable.

  • Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease-free for ≥ 5 years).
  • Current alcohol abuse or drug addiction that in the opinion of the investigator may interfere with the subject's ability to comply with trial procedures.
  • Receipt of blood or blood-derived products in the past three months.
  • Participation in a trial of a high-dose influenza vaccine in the past 12 months.
  • Receipt of influenza vaccine in the past six months.
  • Receipt of any other vaccine in the past four weeks.
  • Planned receipt of any other vaccine in the four weeks following the trial vaccination.
  • Participation in another clinical trial in the past four weeks.
  • Planned participation in another clinical trial during the present trial period.

Note:Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.

  • Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
  • History of Guillain-Barré syndrome.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • An acute febrile illness (oral temperature ≥ 99.5ºF [≥ 37.5ºC]) within 24 hours prior to vaccination. If this contraindication exists, vaccination will be deferred until the participant has been afebrile 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group 1
Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1
Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
0.5 mL, IM
Other Names:
  • Fluzone® High-Dose
Experimental: Study Group 2
Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2
Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
0.5 mL, IM
Other Names:
  • Fluzone® High-Dose
Experimental: Study Group 3
Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3
Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
0.5 mL, IM
Other Names:
  • Fluzone® High-Dose
Active Comparator: Group 4
Participants will receive the Standard Fluzone® vaccine
Biological: Inactivated, Split-Virion Influenza Vaccine
0.5 mL, IM
Other Names:
  • Fluzone® 2006-2007 formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.
Time Frame: Day 0 and Day 28 Post-vaccination
Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.
Day 0 and Day 28 Post-vaccination
Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
Time Frame: Day 28 Post-vaccination
Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer <10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).
Day 28 Post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
Time Frame: Day 0 and Day 28 Post-vaccination
Seroprotection was defined as a Hemagglutination Inhibition Titers of at least 40 (≥ 1:40) for each of the Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) pre- or post-vaccination with Fluzone® High-Dose or Standard Fluzone® vaccines.
Day 0 and Day 28 Post-vaccination
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination
Time Frame: Day 0 to Day 7 Post-vaccination
The occurrence, time to onset, number of days of occurrence, and severity of solicited injection site reactions: Injection Site Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia were collected.
Day 0 to Day 7 Post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 20, 2006

First Submitted That Met QC Criteria

October 20, 2006

First Posted (Estimate)

October 23, 2006

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIM05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Clinical Trials on High-Dose Inactivated, Split-Virion Influenza Vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe